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Review Panel
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Review Panel
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Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
EMF
Knife, Surgical
1
Product Code
EPT
Microscope, Surgical
1
Product Code
EPW
Support, Head, Surgical, Ent
1
Product Code
OEJ
Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia
2
Product Code
FAZ
System, Cryosurgical, Liquid Nitrogen, For Urology
2
Product Code
OEK
Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
2
Product Code
GAG
Stapler, Surgical
2
Product Code
DWG
Electrosurgical Device
2
Product Code
DWH
Blade, Saw, Surgical, Cardiovascular
1
Product Code
DWI
Saw, Electrically Powered
1
Product Code
DWO
Needle, Biopsy, Cardiovascular
1
Product Code
QQS
Stapler, Skin
1
Product Code
BTA
Pump, Portable, Aspiration (Manual Or Powered)
2
Product Code
BWA
Unit, Electrosurgical And Coagulation, With Accessories
2
Product Code
BWN
Table And Attachments, Operating-Room
1
Product Code
BWP
Shoe And Shoe Cover, Conductive
1
Product Code
FGY
Cannula, Injection
1
Product Code
FHM
Apparatus, Suturing, Stomach And Intestinal
1
Product Code
FHR
Needle, Gastro-Urology
1
Product Code
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
2
Product Code
FNW
Pad, Kelly
2
Product Code
FQO
Table, Operating-Room, Ac-Powered
1
Product Code
FQP
Lamp, Operating-Room
2
Product Code
FSE
Table, Operating-Room, Manual
1
Product Code
FSH
Tray, Surgical, Needle
1
Product Code
FSM
Tray, Surgical, Instrument
1
Product Code
FSO
Microscope, Surgical, General & Plastic Surgery
1
Product Code
FSP
Loupe, Diagnostic/Surgical
1
Product Code
FSQ
Light, Surgical, Instrument
2
Product Code
FSS
Light, Surgical, Floor Standing
2
Product Code
FST
Light, Surgical, Fiberoptic
2
Product Code
FSW
Light, Surgical, Endoscopic
2
Product Code
FSX
Light, Surgical, Connector
2
Product Code
FSY
Light, Surgical, Ceiling Mounted
2
Product Code
FSZ
Light, Surgical, Carrier
2
Product Code
FTA
Light, Surgical, Accessories
2
Product Code
FTC
Light, Ultraviolet, Dermatological
2
Product Code
K
23
3811
DT Controlled Phototherapy Equipment
2
Cleared 510(K)
K
22
3882
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
2
Cleared 510(K)
K
23
0382
3 Series NeoLux
2
Cleared 510(K)
K
23
0076
Enhanced AURORA™ Medical Diode System, and related accessories
2
Cleared 510(K)
K
22
0840
1 Series Phototherapy Equipment
2
Cleared 510(K)
K
21
0004
i8 Tanning Booth
2
Cleared 510(K)
K
21
2510
7 Series Phototherapy Device
2
Cleared 510(K)
K
21
0881
M Series Phototherapy Equipment
2
Cleared 510(K)
K
20
2827
308nm Excimer UV-light Skin Therapy System
2
Cleared 510(K)
K
20
0971
308nm Excimer System
2
Cleared 510(K)
K
19
2411
Psoria-Shield AURORA
2
Cleared 510(K)
K
19
2642
308nm Excimer System
2
Cleared 510(K)
K
19
1571
UV Radiation Treatment System
2
Cleared 510(K)
K
19
1086
Exciplex
2
Cleared 510(K)
K
18
1805
UV Phototherapy
2
Cleared 510(K)
K
18
2215
ClearLink Controlled Phototherapy Equipment
2
Cleared 510(K)
K
17
2273
308nm Excimer System
2
Cleared 510(K)
K
17
3436
Luma Light System
2
Cleared 510(K)
K
17
1702
Exciplex308nm
2
Cleared 510(K)
K
17
0489
Skylit Phototherapy System
2
Cleared 510(K)
K
15
3749
3 Series Phototherapy Unit
2
Cleared 510(K)
K
15
1795
ML24000 UVA-1 Phototherapy Cabinet
2
Cleared 510(K)
K
15
0752
GME ExSys 308
2
Cleared 510(K)
K
15
0912
Houva-NET Control System
2
Cleared 510(K)
K
13
4009
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
2
Cleared 510(K)
K
13
2643
UV PHOTOTHERAPY
2
Cleared 510(K)
K
13
0519
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
2
Cleared 510(K)
K
11
1049
MOBILE VERSA LIGHT
2
Cleared 510(K)
K
11
0912
SMART TOUCH UVTHERAPY MULTIPLE MACHINE
2
Cleared 510(K)
K
11
1172
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
2
Cleared 510(K)
K
10
3204
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
2
Cleared 510(K)
K
10
3708
ML24000 UVA-1 PHOTOTHERAPY UNIT
2
Cleared 510(K)
K
10
3540
PSORIA-LIGHT
2
Cleared 510(K)
K
10
0378
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
2
Cleared 510(K)
K
09
1568
LH-75 PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
09
0097
LH-75T PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
08
2731
ML24000 UVA-1 PHOTOTHERAPY CABINET
2
Cleared 510(K)
K
07
3503
VERSA LITE
2
Cleared 510(K)
K
07
3587
DERMAPAL WITH DIGITAL TIMER
2
Cleared 510(K)
K
07
3066
308 DERMATOLOGICAL EXCIMER SYSTEM
2
Cleared 510(K)
K
07
2035
RESOLVE UVB PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
07
0934
PANOSOL II TRU-BLU, MODEL UBL-417
2
Cleared 510(K)
K
06
3621
3 SERIES PHOTOTHERAPY CABINET
2
Cleared 510(K)
K
06
1589
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
2
Cleared 510(K)
K
06
1295
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
2
Cleared 510(K)
K
05
1330
UVBIOTEK MODELS 3200B AND 4000B
2
Cleared 510(K)
K
05
2660
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO
2
Cleared 510(K)
K
05
0080
CYNOSUREA ECLILITE AND ECLILITE U
2
Cleared 510(K)
K
05
0695
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
2
Cleared 510(K)
K
04
2502
3 SERIES PHOTOTHERAPY CABINET
2
Cleared 510(K)
K
04
1212
HOUVA 3 PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
03
3946
LOVELY SYSTEM
2
Cleared 510(K)
K
04
0062
LEVIA PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
03
1800
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
2
Cleared 510(K)
K
02
4020
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
02
2104
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
2
Cleared 510(K)
K
02
1762
BCLEAR
2
Cleared 510(K)
K
02
2165
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
2
Cleared 510(K)
K
02
1514
PHILIPS PLS9W/12/2P UVB
2
Cleared 510(K)
K
02
1092
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
2
Cleared 510(K)
K
02
0591
BCLEAR
2
Cleared 510(K)
K
01
1197
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
98
2082
HANDISOL WOUND HEALING
2
Cleared 510(K)
K
93
5525
PHOTOTHERAPEUTIX MODEL 2480AB
2
Cleared 510(K)
K
93
3954
PHOTOTHERAPEUTIX MODEL 2400B
2
Cleared 510(K)
K
93
3952
PHOTOTHERAPEUTIX MODEL 800B
2
Cleared 510(K)
K
93
3953
PHOTOTHERAPEUTIX MODEL 1650B
2
Cleared 510(K)
K
93
5524
PHOTOTHERAPEUTIX MODEL 3200A
2
Cleared 510(K)
K
93
5526
PHOTOTHERAPEUTIX MODEL 1600B
2
Cleared 510(K)
K
93
5572
SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT
2
Cleared 510(K)
K
93
5840
TL 20W/12/RS & TL 40W/12/RS
2
Cleared 510(K)
K
93
4808
UVISOL AND UVISOL II
2
Cleared 510(K)
K
93
3146
ESB 2400 SEI
2
Cleared 510(K)
K
93
0856
PSORALITE
2
Cleared 510(K)
K
92
4969
PHOTOTHERAPY TIMER
2
Cleared 510(K)
K
92
5171
FREE SUN PRO DESIGN 3000 AND 3800
2
Cleared 510(K)
K
92
4077
HANDISOL
2
Cleared 510(K)
K
92
2963
TL100W/12
2
Cleared 510(K)
K
91
5426
MEDICAL SUNLAMP FOR PHOTOTHERAPY
2
Cleared 510(K)
K
91
3760
PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
2
Cleared 510(K)
K
91
0767
TL100W/01 UVB LAMP
2
Cleared 510(K)
K
90
4427
PANOSOL II UVB-206
2
Cleared 510(K)
K
90
4426
PANOSOL II UVA-218
2
Cleared 510(K)
K
90
4428
PANOSOL II UAB-228
2
Cleared 510(K)
K
90
4425
MODEL 6/01 UV-B FIXTURE
2
Cleared 510(K)
K
90
1324
U.V. SUNLAMP 95UF-II
2
Cleared 510(K)
K
90
0649
FLUORESCENT T12 UVA LAMP
2
Cleared 510(K)
K
90
0693
U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
2
Cleared 510(K)
K
89
6831
ALISUN SUNTANNING BED
2
Cleared 510(K)
K
89
6191
SUNTANNING BED, INC. T12 UVA TANNING LAMPS
2
Cleared 510(K)
K
89
5410
REMINGTON TANFASTIC HANDHELD TANNING WAND
2
Cleared 510(K)
K
88
5026
HOUVA II UVB
2
Cleared 510(K)
K
88
5029
HOUVA II UVA/UVB
2
Cleared 510(K)
K
89
0084
PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
2
Cleared 510(K)
K
88
5184
SHAW SUN SYSTEMS MODEL 2400
2
Cleared 510(K)
K
88
5025
HOUVA II UVA
2
Cleared 510(K)
K
88
3929
TANNING BED
2
Cleared 510(K)
K
88
3952
U. V. SUNLAMP 95UF-11
2
Cleared 510(K)
K
88
2722
HOUVA-BED
2
Cleared 510(K)
K
88
1923
ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72
2
Cleared 510(K)
K
88
1385
PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL
2
Cleared 510(K)
K
87
4889
U.V. SUNLAMP 95 UF-11
2
Cleared 510(K)
K
87
3430
FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12
2
Cleared 510(K)
K
87
2648
SOLAR GOLD UVA SUN TANNING BED
2
Cleared 510(K)
K
87
2651
PANOSOL 2000 624-414
2
Cleared 510(K)
K
87
2650
PANOSOL 2000 624-604
2
Cleared 510(K)
K
87
2649
HAND/FOOT UVA/UVB 624-224
2
Cleared 510(K)
K
87
2707
PANOSOL 2000 624-404
2
Cleared 510(K)
K
87
2706
PANOSOL 2000 624-616
2
Cleared 510(K)
K
87
2605
HAND/FOOT UVA 624-218
2
Cleared 510(K)
K
87
2604
HAND/FOOT 624-208
2
Cleared 510(K)
K
87
1237
SUN CAPSULE I & II SUNTANNING BOOTH
2
Cleared 510(K)
K
87
0167
U.V. SUNLAMP 95UF-11
2
Cleared 510(K)
K
86
4511
PSORALITE 18400 SERIES
2
Cleared 510(K)
K
86
4510
PSORALITE 12800 SERIES
2
Cleared 510(K)
K
86
4546
MAXI-TAN DEVICE
2
Cleared 510(K)
K
86
4907
SUNTANNING LAMP
2
Cleared 510(K)
K
86
4485
SUNFIT SUNLAMP
2
Cleared 510(K)
K
86
3937
OSRAM ULTRAMED 400 W
2
Cleared 510(K)
K
86
3555
BREMI BEAUTY BRONZE
2
Cleared 510(K)
K
86
3518
WEINGART MODEL 1000 SUNLAMP PRODUCT
2
Cleared 510(K)
K
86
2608
SPERTILITE PHOTOTHERAPY LAMP
2
Cleared 510(K)
K
86
2372
ULTRATAN TANNING SYSTEM
2
Cleared 510(K)
K
86
2341
TANNING SOFA
2
Cleared 510(K)
K
86
1963
ULTRALITE HF1236 HAND AND FOOT SYSTEM
2
Cleared 510(K)
K
86
2263
PERSUNAL TAN, MODEL NO. HU-0208L
2
Cleared 510(K)
K
86
2142
SUN-DREAMER SUNTANNING BED
2
Cleared 510(K)
K
86
2097
FACE TANNER
2
Cleared 510(K)
K
86
1989
MODIFICATION OF SUNTANA SUN SYSTEM BED
2
Cleared 510(K)
K
86
1705
CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP)
2
Cleared 510(K)
K
86
1636
MIAMI-SUNNY
2
Cleared 510(K)
K
86
1570
ALPHA TAN 1000 AND ALPHA TAN 1200
2
Cleared 510(K)
K
86
1447
ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900
2
Cleared 510(K)
K
86
1533
SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS
2
Cleared 510(K)
K
86
1107
TAN MATE HOME TANNING UNIT
2
Cleared 510(K)
K
86
1076
RESIDENTIAL TANNING UNIT
2
Cleared 510(K)
K
86
0932
ULTRASUN 1000 & 2000 SUNTANNING UNIT
2
Cleared 510(K)
K
86
0931
ULTRASUN 3000 AND 5000 SUNTANNING UNIT
2
Cleared 510(K)
K
86
0930
ULTRASUN 2500 SUNTANNING UNIT
2
Cleared 510(K)
K
86
0929
ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT
2
Cleared 510(K)
K
86
0859
UVA SUN SYSTEMS
2
Cleared 510(K)
K
86
0856
SILGMANN SOLARIUM SUN-MOBIL MODEL 0918
2
Cleared 510(K)
K
86
0370
SAFE SUN 700 HOME TANNING UNIT
2
Cleared 510(K)
K
86
0567
NORDIC SUN HOME TANNING UNIT
2
Cleared 510(K)
K
86
0566
NORDIC SUN 24 LAMP TANNING BED
2
Cleared 510(K)
K
86
0509
SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE
2
Cleared 510(K)
K
86
0489
EUROTAN BY AYK
2
Cleared 510(K)
K
86
0198
MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING
2
Cleared 510(K)
K
85
4750
TOP SUN
2
Cleared 510(K)
K
86
0347
SUNLAMP MODELS 24N, 30R, 30RE, 37RE
2
Cleared 510(K)
K
86
0144
SUM TAN VI
2
Cleared 510(K)
K
85
5162
ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR
2
Cleared 510(K)
K
86
0117
KRYPTOSOL (SUN LAMP)
2
Cleared 510(K)
K
85
4932
ECUMOL ULTRAVIOLET FACE TANNING UNITS
2
Cleared 510(K)
K
85
4707
SUNTAINNING BOOTH
2
Cleared 510(K)
K
85
4594
PHOENIX U.V.A. SUNTAN BEDS
2
Cleared 510(K)
K
85
4498
SPECTRA 724
2
Cleared 510(K)
K
85
4515
SHAW SUN SYSTEMS 1000, 2000 & 3200
2
Cleared 510(K)
K
85
4020
G-T 1000
2
Cleared 510(K)
K
85
4224
GOLDEN RULE SUN TANNING BEDS
2
Cleared 510(K)
K
85
4170
I.S.M. PRODUCT FAMILY MODEL R3600C
2
Cleared 510(K)
K
85
4154
FOX BED MODEL 2001
2
Cleared 510(K)
K
85
4131
PHASE V-MODEL 1500 RUVA
2
Cleared 510(K)
K
85
4111
EXPRESS TAN SUN CANOPY
2
Cleared 510(K)
K
85
2534
ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
2
Cleared 510(K)
K
85
4171
I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC
2
Cleared 510(K)
K
85
4004
FLUORESCENT T12 UVA TANNING LAMP
2
Cleared 510(K)
K
85
3846
SUN TANNING BED
2
Cleared 510(K)
K
85
3833
TOP SUN MODELS 100,101,103 &139, 139-1, 139-3
2
Cleared 510(K)
K
85
3911
UV-A SUNTANNING EQUIPMENT
2
Cleared 510(K)
K
85
3752
SUN KING
2
Cleared 510(K)
K
85
3679
SUNJET MODELS 240/280
2
Cleared 510(K)
K
85
3692
SUN TANNING BED MODEL EC-3RF
2
Cleared 510(K)
K
85
3587
UVATAN INDUS. UVATAN 900C, 900B/800 & 600C
2
Cleared 510(K)
K
85
3545
FLOURESCENT T12 UVA TANNING LAMP
2
Cleared 510(K)
K
85
3394
600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L
2
Cleared 510(K)
K
85
3248
CHALLENGER SUNRISE
2
Cleared 510(K)
K
85
3177
ECUMOL ULTRAVIOLET SUNTANNNING BEDS
2
Cleared 510(K)
K
85
3046
TAN MODEL I
2
Cleared 510(K)
K
85
2957
SAHARA SUNBED
2
Cleared 510(K)
K
85
2684
WALDMANN F85/100W UV21
2
Cleared 510(K)
K
85
2576
WALDMANN F85/100W UV6
2
Cleared 510(K)
K
85
1408
SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER
2
Cleared 510(K)
K
85
2579
THE SUNTANNING CO. TANNING BED
2
Cleared 510(K)
K
85
2348
PHILIPS SOLARIUM HP 3134
2
Cleared 510(K)
K
85
2243
KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS
2
Cleared 510(K)
K
85
2290
PRIVATAN HOME TANNING CENTER
2
Cleared 510(K)
K
85
2149
PORTASUN MODEL 600/LI SUNLAMP
2
Cleared 510(K)
K
85
2053
ORIGINAL ULTRAVIOLET SUNTANNING LAMP
2
Cleared 510(K)
K
85
1858
FOLD AWAY HUT
2
Cleared 510(K)
K
85
1859
FACIAL/UPPER BODY UNIT
2
Cleared 510(K)
K
84
5029
SURGICAL POWER MAGNET
2
Cleared 510(K)
K
85
1532
SUNTANNING EQUIPMENT
2
Cleared 510(K)
K
85
1536
PHILIPS UV-A SOLARIUM TYPE HP 3141
2
Cleared 510(K)
K
85
1535
PHILIPS UV-A SOLARIUM TYPE HP 3140
2
Cleared 510(K)
K
85
1534
PHILIPS UV-A SOLARIUM TYPE HP 3150
2
Cleared 510(K)
K
85
1533
PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP
2
Cleared 510(K)
K
85
1255
SUN BEDS
2
Cleared 510(K)
K
85
0660
SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY
2
Cleared 510(K)
K
85
0493
SUNSHOWER MODEL HU-01-12L
2
Cleared 510(K)
K
85
0203
PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP
2
Cleared 510(K)
K
85
0204
PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP
2
Cleared 510(K)
K
85
0206
PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP
2
Cleared 510(K)
K
85
0205
PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP
2
Cleared 510(K)
K
84
5001
MARTANIQUE 6-TUBE HOME SOLARIUM
2
Cleared 510(K)
K
85
0042
SOLAR TAN - SOLARIA IV
2
Cleared 510(K)
K
84
5028
MARTANIQUE 7-TUBE RUVA HOME SOLARIUM
2
Cleared 510(K)
K
84
4870
SUNTAN CONNECTIONS BAHAMA SUN-BOOTH
2
Cleared 510(K)
K
84
3902
SOLAR-GOLD UV-A BY EOS
2
Cleared 510(K)
K
84
4039
AZTECH INDUSTRIES SUNTANNING BED AZ100
2
Cleared 510(K)
K
84
3306
UVA SUNTANNING UNITS VARIOUS MODELS
2
Cleared 510(K)
K
84
3814
EMUMOL ULTRAVIOLET SUNTANNING LAMP
2
Cleared 510(K)
K
84
3647
MTI 1200, 401 & 3500
2
Cleared 510(K)
K
84
2975
BROWNIE BOOTH BB1
2
Cleared 510(K)
K
84
2787
SUNBED
2
Cleared 510(K)
K
84
2575
ULTRA-VIOLET A SOURCE LIGHT EMITTING
2
Cleared 510(K)
K
84
2384
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT
2
Cleared 510(K)
K
84
1614
SUN BEDS
2
Cleared 510(K)
K
84
0931
SUN BEDS
2
Cleared 510(K)
K
84
0158
KOSMEDICO GMBH SUNLAMP PRODUCTS
2
Cleared 510(K)
K
84
0132
TANSEEKER
2
Cleared 510(K)
K
84
0133
ULTRAVIOLET TANNING SYSTEMS
2
Cleared 510(K)
K
84
0137
SILGMANN SOLARIUM S-TYPE 1218 COMBO
2
Cleared 510(K)
K
83
4488
MERRITTAN SUN SYSTEM
2
Cleared 510(K)
K
83
3524
SUNBED/SUNROOF TANNING DEVICE
2
Cleared 510(K)
K
83
4495
UV-A SUNTANNING EQUIPMENT 1000-8000
2
Cleared 510(K)
K
83
4493
EVERTAN SUNTAN BEDS
2
Cleared 510(K)
K
83
4492
SALON -BODY TANNING BED
2
Cleared 510(K)
K
83
4491
UVA SUNTANNING LAMPS
2
Cleared 510(K)
K
83
3511
UV-A SUNTANNING EQUIPMENT-SILGMANN
2
Cleared 510(K)
K
83
3490
SILGMANN SOLARIUMS-TYPE 1218 CANOPY &
2
Cleared 510(K)
K
83
3350
KOSMEDICO GMBH SUN LAMP
2
Cleared 510(K)
K
83
3527
UV-A SUN TANNING EQUIPMENT
2
Cleared 510(K)
K
83
3240
INT'L TANNING SYSTEMS B.V
2
Cleared 510(K)
K
83
2794
SUNTANNING BOOTHS AND BEDS
2
Cleared 510(K)
K
82
7890
FOLDALITE UNIT
2
Cleared 510(K)
K
82
0492
SPECTRA305
2
Cleared 510(K)
K
81
2225
METEC HELARIUM LOUNGE & SKY UNITS
2
Cleared 510(K)
K
82
0123
SUNFLOWER
2
Cleared 510(K)
K
81
3307
UVA HEX UNIT
2
Cleared 510(K)
K
81
2663
SOLARIUM COMBINATION
2
Cleared 510(K)
K
81
2446
SUNLAMP
2
Cleared 510(K)
K
81
2579
SUNTANNING HOME UNIT
2
Cleared 510(K)
K
81
2543
TANARAMA
2
Cleared 510(K)
K
81
2521
SUNTANNING DEVICE (SEPAR. FROM K812225)
2
Cleared 510(K)
K
81
1870
UVA SUN TANNING EQUIPMENT
2
Cleared 510(K)
K
81
1585
F72T12/BL-S/HO UVA SUNLAMP
2
Cleared 510(K)
K
81
1586
F72T12/BL-S/SHO-O UVA SUNLAMP
2
Cleared 510(K)
K
81
0796
SUNTAN BOOTH
2
Cleared 510(K)
K
81
1029
SUNLAMP
2
Cleared 510(K)
K
80
3264
SUNLAMP
2
Cleared 510(K)
K
81
0688
THE SUNFACTORY
2
Cleared 510(K)
K
81
0476
B.J.'S UVA SUN TAN BED W/SUN ROOF
2
Cleared 510(K)
K
80
1017
TANIT COMMERCIAL SUNTAN BOOTH
2
Cleared 510(K)
K
80
0950
TANIT HOME SUNTANNING UNIT
2
Cleared 510(K)
K
80
0160
SUN-TANNING BOOTHS
2
Cleared 510(K)
K
79
2500
UVB LIGHT BOX - UVB LIGHT BOOTH
2
Cleared 510(K)
K
79
0167
SUNLAMP
2
Cleared 510(K)
K
77
0862
BLACK LAMPS,F72T12/BL/HO
2
Cleared 510(K)
K
76
1179
PSORALITE
2
Cleared 510(K)
K
76
1186
HOUVA-LITE ARM UNIT #601
2
Cleared 510(K)
K
76
1189
HOUVA-LITE SOLE UNIT #502
2
Cleared 510(K)
K
76
1188
HOUVA-LITE PALM UNIT #501
2
Cleared 510(K)
K
76
1187
HOUVA-LITE LEG UNIT #701
2
Cleared 510(K)
K
76
0471
LAMP, FLOURESCENT BLACK, HIGH OUTPUT
2
Cleared 510(K)
K
76
0482
SUNLAMP (F40-UVB & F20-UVB)
2
Cleared 510(K)
FTD
Lamp, Surgical
2
Product Code
FTF
Illuminator, Non-Remote
2
Product Code
FTG
Illuminator, Remote
2
Product Code
FTH
Camera, Still, Microsurgical
1
Product Code
FTS
Camera, Cine, Endoscopic, With Audio
1
Product Code
FTT
Camera, Still, Surgical
1
Product Code
FTX
Mirror, General & Plastic Surgery
1
Product Code
FTY
Tape, Measuring, Rulers And Calipers
1
Product Code
FWB
Camera, Television, Surgical, Without Audio
1
Product Code
FWC
Camera, Television, Surgical, With Audio
1
Product Code
FWD
Camera, Television, Microsurgical, Without Audio
1
Product Code
FWE
Camera, Television, Microsurgical, With Audio
1
Product Code
FWF
Camera, Television, Endoscopic, Without Audio
1
Product Code
FWG
Camera, Television, Endoscopic, With Audio
1
Product Code
FWH
Camera, Cine, Surgical, Without Audio
1
Product Code
FWI
Camera, Cine, Surgical, With Audio
1
Product Code
FWJ
Camera, Cine, Microsurgical, Without Audio
1
Product Code
FWK
Camera, Cine, Microsurgical, With Audio
1
Product Code
FWL
Camera, Cine, Endoscopic, Without Audio
1
Product Code
FWW
Table, Operating-Room, Pneumatic
1
Product Code
FWX
Table, Operating-Room, Mechanical
1
Product Code
FWY
Table, Operating-Room, Non-Electrical
1
Product Code
FWZ
Operating Room Accessories Table Tray
1
Product Code
FXM
Camera, Still, Endoscopic
1
Product Code
FXN
Tape, Camera, Surgical
1
Product Code
FXQ
Lens, Camera, Surgical
1
Product Code
FXR
Holder, Camera, Surgical
1
Product Code
FXS
Frame, Camera, Surgical
1
Product Code
FXT
Film, Camera, Surgical
1
Product Code
FXW
Shoes, Operating-Room
1
Product Code
FYE
Dress, Surgical
1
Product Code
FYF
Cap, Surgical
1
Product Code
FZK
Chair, Surgical, Non-Electrical
1
Product Code
FZM
Stool, Operating-Room
1
Product Code
FZO
Chisel, Surgical, Manual
1
Product Code
FZP
Clip, Implantable
2
Product Code
FZQ
Clip, Removable (Skin)
1
Product Code
FZR
Contractor, Surgical
1
Product Code
FZS
Curette, Surgical, General Use
1
Product Code
FZT
Cutter, Surgical
1
Product Code
FZW
Expander, Surgical, Skin Graft
1
Product Code
FZX
Guide, Surgical, Instrument
1
Product Code
FZY
Hammer, Surgical
1
Product Code
FZZ
Marker, Skin
1
Product Code
GAA
Needle, Aspiration And Injection, Disposable
1
Product Code
GAB
Needle, Suturing, Disposable
1
Product Code
GAC
Rasp, Surgical, General & Plastic Surgery
1
Product Code
GAD
Retractor
1
Product Code
GAE
Snare, Surgical
1
Product Code
GAF
Spatula, Surgical, General & Plastic Surgery
1
Product Code
GAH
Stylet, Surgical, General & Plastic Surgery
1
Product Code
GAI
Stripper, Vein, Reusable
1
Product Code
GAJ
Stripper, Vein, Disposable
1
Product Code
GAK
Suture, Absorbable
2
Product Code
GAL
Suture, Absorbable, Natural
2
Product Code
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
2
Product Code
GAN
Suture, Absorbable, Synthetic
2
Product Code
GAO
Suture, Nonabsorbable
2
Product Code
GAP
Suture, Nonabsorbable, Silk
2
Product Code
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
2
Product Code
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
2
Product Code
GAS
Suture, Nonabsorbable, Synthetic, Polyester
2
Product Code
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
2
Product Code
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
2
Product Code
GBA
Catheter, Balloon Type
1
Product Code
GBB
Chair, Surgical, Ac-Powered
1
Product Code
GBC
Lamp, Surgical, Incandescent
2
Product Code
GBN
Catheter, Pediatric, General & Plastic Surgery
1
Product Code
GBO
Catheter, Nephrostomy, General & Plastic Surgery
1
Product Code
GBP
Catheter, Multiple Lumen
1
Product Code
GBQ
Catheter, Continuous Irrigation
1
Product Code
GBS
Catheter, Ventricular, General & Plastic Surgery
1
Product Code
GBW
Catheter, Peritoneal
1
Product Code
GBX
Catheter, Irrigation
1
Product Code
GBY
Catheter, Eustachian, General & Plastic Surgery
1
Product Code
GBZ
Catheter, Cholangiography
1
Product Code
GCB
Needle, Catheter
1
Product Code
GCC
Dilator, Catheter
1
Product Code
GCD
Connector, Catheter
1
Product Code
GCE
Adaptor, Catheter
1
Product Code
GCY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
1
Product Code
GCZ
Retainer, Surgical
1
Product Code
GDC
Table, Operating-Room, Electrical
1
Product Code
GDF
Guide, Needle, Surgical
1
Product Code
GDG
Hook, Surgical, General & Plastic Surgery
1
Product Code
GDH
Gouge, Surgical, General & Plastic Surgery
1
Product Code
GDI
Dissector, Surgical, General & Plastic Surgery
1
Product Code
GDJ
Clamp, Surgical, General & Plastic Surgery
1
Product Code
GDL
Needle, Suturing, Reusable
1
Product Code
GDM
Needle, Aspiration And Injection, Reusable
1
Product Code
GDN
Knife, Amputation
1
Product Code
GDO
Applier, Surgical, Clip
1
Product Code
GDR
Saw, Manual And Accessories
1
Product Code
GDT
Staple, Removable (Skin)
1
Product Code
GDW
Staple, Implantable
2
Product Code
GDX
Scalpel, One-Piece
1
Product Code
GDY
Gauze/Sponge, Internal, X-Ray Detectable
1
Product Code
GDZ
Handle, Scalpel
1
Product Code
GEA
Cannula, Surgical, General & Plastic Surgery
1
Product Code
GEC
Brush, Scrub, Operating-Room
1
Product Code
GED
Brush, Dermabrasion, Manual
1
Product Code
GEE
Brush, Biopsy, General & Plastic Surgery
1
Product Code
GEF
Applier, Staple, Surgical,
1
Product Code
GEG
Elevator, Surgical, General & Plastic Surgery
1
Product Code
GEH
Unit, Cryosurgical, Accessories
2
Product Code
GEI
Electrosurgical, Cutting & Coagulation & Accessories
2
Product Code
GEJ
Carrier, Ligature
1
Product Code
GEN
Forceps, General & Plastic Surgery
1
Product Code
GEO
File, Surgical, General & Plastic Surgery
1
Product Code
GES
Blade, Scalpel
1
Product Code
GET
Motor, Surgical Instrument, Pneumatic Powered
1
Product Code
GEX
Powered Laser Surgical Instrument
2
Product Code
GEY
Motor, Surgical Instrument, Ac-Powered
1
Product Code
GFA
Blade, Saw, General & Plastic Surgery, Surgical
1
Product Code
GFB
Head, Surgical, Hammer
1
Product Code
GFC
Driver, Surgical, Pin
1
Product Code
GFD
Dermatome
1
Product Code
GFE
Brush, Dermabrasion, Powered
1
Product Code
GFF
Bur, Surgical, General & Plastic Surgery
1
Product Code
GFG
Bit, Surgical
1
Product Code
GFI
Osteotome, Manual
1
Product Code
GFJ
Mallet, Surgical, General & Plastic Surgery
1
Product Code
HAB
Saw, Powered, And Accessories
1
Product Code
HAM
Apparatus, Electrosurgical
2
Product Code
HBI
Illuminator, Fiberoptic, Surgical Field
2
Product Code
HBT
Applier, Hemostatic Clip
1
Product Code
HCF
Instrument, Ligature Passing And Knot Tying
1
Product Code
HJE
Lamp, Fluorescein, Ac-Powered
2
Product Code
HMP
Pad, Eye
1
Product Code
HRB
Microscope, Operating, Non-Electric, Ophthalmic
1
Product Code
HRM
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
1
Product Code
HRQ
Hemostat
1
Product Code
HSO
Saw
1
Product Code
HTC
Pliers, Surgical
1
Product Code
HTD
Forceps
1
Product Code
HTE
Elevator
1
Product Code
HTF
Curette
1
Product Code
HTR
Rasp
1
Product Code
HTZ
Instrument, Cutting, Orthopedic
1
Product Code
HWM
Osteotome
1
Product Code
HXD
Clamp
1
Product Code
HXL
Mallet
1
Product Code
HXR
Spatula, Orthopedic
1
Product Code
HXT
Tape, Orthopedic
1
Product Code
HYA
Forceps, Wire Holding
1
Product Code
JCX
Apparatus, Suction, Ward Use, Portable, Ac-Powered
2
Product Code
JCY
Catheter, Infusion
1
Product Code
JEA
Table, Surgical With Orthopedic Accessories, Ac-Powered
1
Product Code
JEB
Table, Surgical With Orthopedic Accessories, Manual
1
Product Code
JOS
Electrode, Electrosurgical
2
Product Code
JOT
Electrode, Gel, Electrosurgical
2
Product Code
JYC
Cannula, Ear
1
Product Code
JYD
Chisel, Mastoid
1
Product Code
KAM
Cannula, Sinus
1
Product Code
KAN
Chisel, Nasal
1
Product Code
KCE
Cannulae, Bronchial
1
Product Code
KDC
Instrument, Surgical, Disposable
1
Product Code
KDD
Kit, Surgical Instrument, Disposable
1
Product Code
KDG
Chisel (Osteotome)
1
Product Code
KFK
Saw, Pneumatically Powered
1
Product Code
KGL
Cabinet, Phototherapy (Puva)
2
Product Code
KGS
Retention Device, Suture
1
Product Code
KGW
Ring (Wound Protector), Drape Retention, Internal
2
Product Code
KGY
Bag, Intestine
1
Product Code
KGZ
Accessories, Catheter
1
Product Code
KIK
Hook, Bone
1
Product Code
KOX
Solvent, Adhesive Tape
1
Product Code
KOY
Degreaser, Skin, Surgical
1
Product Code
KOZ
Beads, Hydrophilic, For Wound Exudate Absorption
1
Product Code
KQM
Camera, Surgical And Accessories
1
Product Code
LEJ
Booth, Sun Tan
2
Product Code
LMF
Agent, Absorbable Hemostatic, Collagen Based
3
Product Code
LMG
Agent, Absorbable Hemostatic, Non-Collagen Based
3
Product Code
LRO
General Surgery Tray
2
Product Code
LRP
Tray, Surgical
1
Product Code
LRW
Scissors, General, Surgical
1
Product Code
LRY
Punch, Surgical
1
Product Code
LRZ
Screwdriver, Surgical
1
Product Code
LSA
Vise, Bench, Surgical
1
Product Code
LWG
Surgical Table Cushion
1
Product Code
LWK
Razor, Surgical
1
Product Code
LXK
Scrapper, Skin Specimen
1
Product Code
LXZ
Guard, Instrument
1
Product Code
LYV
Label Or Tag, Sterile
1
Product Code
LZM
Guard, Skin Graft
1
Product Code
MCH
Clip, Hemostatic
2
Product Code
MCZ
Suture Removal Kit
1
Product Code
MDA
Elastomer, Silicone, For Scar Management
1
Product Code
MDM
Instrument, Manual, Surgical, General Use
1
Product Code
MGO
Closure, Wound, Adhesive
1
Product Code
MIJ
Needle, Tumor Localization
1
Product Code
MJG
Device, Percutaneous, Biopsy
1
Product Code
MKY
System, Skin Closure
1
Product Code
MOQ
Battery, Replacement, Rechargeable
1
Product Code
MPN
Tissue Adhesive For The Topical Approximation Of Skin
2
Product Code
MUL
Generator, Electrosurgical, Coagulation, Cancer
2
Product Code
MUU
System, Suction, Lipoplasty
2
Product Code
MVR
Device, Anastomotic, Microvascular
2
Product Code
MWY
System, Microwave, Hair Removal
2
Product Code
MXG
Lamp, Uvc, (For Treating Skin And Wounds)
2
Product Code
MXW
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
2
Product Code
NAB
Gauze / Sponge,Nonresorbable For External Use
1
Product Code
NAC
Dressing, Wound, Hydrophilic
1
Product Code
NAD
Dressing, Wound, Occlusive
1
Product Code
NAE
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
1
Product Code
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
2
Product Code
NCA
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
2
Product Code
NEH
Anchor, Fascial
2
Product Code
NEU
Marker, Radiographic, Implantable
2
Product Code
NEW
Suture, Surgical, Absorbable, Polydioxanone
2
Product Code
NEY
System, Ablation, Microwave And Accessories
2
Product Code
NJC
Clip, Vas Deferens
2
Product Code
NJU
Suture, Nonabsorbable, Nitinol
2
Product Code
NJZ
Extractor, Vein
1
Product Code
NLK
Needle, Biopsy, Cardiovascular, Reprocessed
1
Product Code
NLL
Staple, Implantable, Reprocessed
2
Product Code
NMJ
Clip, Implantable, Reprocessed
2
Product Code
NMT
Needle, Catheter, Reprocessed
1
Product Code
NMU
Needle, Gastro-Urology, Reprocessed
1
Product Code
NNA
Biopsy Device, Percutaneous, Reprocessed
1
Product Code
NNC
Needle, Aspiration And Needle, Reprocessed
1
Product Code
NRB
Wound Cleaner, Ultrasound
2
Product Code
NRJ
Ultrasound, Skin Permeation
2
Product Code
NTB
System, Ablation, Ultrasound And Accessories
2
Product Code
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
2
Product Code
NUV
Massager, Vacuum, Light Induced Heating
2
Product Code
NVH
Suture, Knot, Mechanical
2
Product Code
NVJ
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
2
Product Code
NWF
Drill, Battery Powered, Subungual Hematoma
1
Product Code
NWJ
Suture, Recombinant Technology
2
Product Code
NXF
Gas, Laser Generating
1
Product Code
NYS
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
2
Product Code
OAB
Low Energy Direct Current Thermal Ablation System
2
Product Code
ODR
Electrosurgical Patient Return Electrode
2
Product Code
OEI
Drainage Catheter With Antibiotic
2
Product Code
OEL
Laser, Benign Prostatic Hyperplasia
2
Product Code
OHO
First Aid Kit Without Drug
1
Product Code
OHS
Light Based Over The Counter Wrinkle Reduction
2
Product Code
OHT
Light Based Over-The-Counter Hair Removal
2
Product Code
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
2
Product Code
OJJ
Burn Kit Without Drug
1
Product Code
OJR
Vacuum Powered Body Fluid Collection Kit
2
Product Code
OJT
Aspiration Tray
1
Product Code
OJU
Skin Prep Tray
1
Product Code
OJV
Single Use Instrument Tray
1
Product Code
OUH
Skin Resurfacing Rf Applicator
2
Product Code
OUP
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
2
Product Code
OJW
Shave Prep Kit
2
Product Code
OKJ
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
2
Product Code
OKO
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
2
Product Code
OLP
Over-The-Counter Powered Light Based Laser For Acne
2
Product Code
OMD
Cutaneous Tissue Adhesive With Mesh
2
Product Code
OMP
Negative Pressure Wound Therapy Powered Suction Pump
2
Product Code
ONE
Powered Light Based Non-Laser Surgical Instrument
2
Product Code
ONF
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
2
Product Code
ONG
Powered Laser Surgical Instrument With Microbeam\Fractional Output
2
Product Code
ONQ
Electrosurgical Coagulation For Aesthetic
2
Product Code
OOK
Dermal Cooling Pack/Vacuum/Massager
2
Product Code
ORE
Cryogenic, Skin Tag Removal, Otc
2
Product Code
ORK
Laser Assisted Lipolysis
2
Product Code
OTK
Wound Drain Catheter System
2
Product Code
OUB
Instrument For Treatment Of Hyperhidrosis
2
Product Code
OVN
Suture Kit
2
Product Code
OXT
Percutaneous Surgical Set With Attachments
2
Product Code
OYW
Laser, Cellulite Appearance
2
Product Code
PAY
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
2
Product Code
PBX
Massager, Vacuum, Radio Frequency Induced Heat
2
Product Code
PBY
Temporary Tissue Marker
2
Product Code
PDG
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
2
Product Code
PDW
Internal Tissue Marker
2
Product Code
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
2
Product Code
PFP
Silicone Hydrogel For Scar Management
1
Product Code
PGZ
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
2
Product Code
PJK
Tissue Adhesive For Internal Use
3
Product Code
PKD
Laceration Tray
1
Product Code
PKE
Laparoscopic Cholecystectomy Kit
1
Product Code
PKO
Transparent Patch For Use In Treatment Of Tattoos
2
Product Code
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
2
Product Code
PMC
Scalp Cooling System
2
Product Code
PMX
Absorbable Collagen Hemostatic Agent With Thrombin
3
Product Code
PNL
Magnetic Surgical System
2
Product Code
POD
Temporary, Internal Use Hemostatic
2
Product Code
PQI
Wound Retraction And Protection System
2
Product Code
PSN
Light Based Imaging
2
Product Code
PTX
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
2
Product Code
PUI
Drape, Surgical, Exempt
2
Product Code
PXN
Basic Set-Up Tray
1
Product Code
PXO
Bone Marrow Biopsy Tray
1
Product Code
PXP
Breast Biopsy / Localization Tray
1
Product Code
QRL
Multiple Use Blood Lancet For Single Patient Use Only
2
Product Code
PXQ
Burn Dressing Tray
1
Product Code
PXR
Cement And Bone Removal Kit
1
Product Code
PXS
Cholecystectomy Kit
1
Product Code
PXU
Fluid Drainage Tray
1
Product Code
PXV
General Purpose Instrument Tray
1
Product Code
PXW
Herniorraphy Kit
1
Product Code
PXX
Incision Tray
1
Product Code
PXY
Irrigation Kit (Wounds)
1
Product Code
PXZ
Laparascopic Sphincterotomy Kit
1
Product Code
PYA
Liver Biopsy Kit
1
Product Code
PYB
Minor Surgical Procedures Tray
1
Product Code
PYC
Paracentesis Tray
1
Product Code
PYD
Pelviscopy Kit
1
Product Code
PYE
Staple Removal Kit
1
Product Code
PYF
Sterile Puncture Tray
1
Product Code
PYG
Suction Catheter Kit
1
Product Code
PYH
Surgical Retractor Kit
1
Product Code
PYI
Thoracic Catheter Insertion Tray
1
Product Code
PYJ
Ulcer Wound Tray
1
Product Code
PYK
Venous Ulcer Kit
1
Product Code
PYL
Wound Drainage Kit
1
Product Code
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
2
Product Code
PZQ
General Laparoscopic Power Morcellation Containment System
2
Product Code
QAI
Powered Microneedle Device
2
Product Code
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
2
Product Code
QCR
Wound Autofluorescence Imaging Device
2
Product Code
QCY
Laser Absorbing Particles
2
Product Code
QDF
Parathyroid Autofluorescence Detection Device
2
Product Code
QDG
Parathyroid Autofluorescence Imaging Device
2
Product Code
QRM
Multiple Use Blood Lancet For Multiple Patient Use
3
Product Code
QFC
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
2
Product Code
QHF
Energy Based Device For Treatment Of Tattoos
2
Product Code
QJF
Autofluorescence Imaging Adjunct Tool For Wounds
2
Product Code
QKL
Lipoaspirate Washing System For Aesthetic Body Contouring
2
Product Code
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
2
Product Code
QPB
System, Suction, Lipoplasty For Removal
2
Product Code
QPX
Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
2
Product Code
QPZ
Contact Cooling For Skin Lesion Pain Relief
2
Product Code
RAB
Sunlamp Products (Pre-Standard)
2
Product Code
REF
Suntan Bed
2
Product Code
REG
Suntan Lamp
2
Product Code
REH
Tabletop Sunlamp System
2
Product Code
QUB
Suction Lipoplasty System For Removal And Transfer
2
Product Code
QVJ
Low Power Electrosurgical Devices For Skin Lesion Destruction
2
Product Code
QZN
Multi-Photon Imaging
2
Product Code
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-e—surgical-devices
/
FTC
/
K073066
View Source
308 DERMATOLOGICAL EXCIMER SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K073066
510(k) Type
Traditional
Applicant
QUANTEL MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/26/2007
Days to Decision
57 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
EMF
Knife, Surgical
EPT
Microscope, Surgical
EPW
Support, Head, Surgical, Ent
OEJ
Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia
FAZ
System, Cryosurgical, Liquid Nitrogen, For Urology
OEK
Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
GAG
Stapler, Surgical
DWG
Electrosurgical Device
DWH
Blade, Saw, Surgical, Cardiovascular
DWI
Saw, Electrically Powered
DWO
Needle, Biopsy, Cardiovascular
QQS
Stapler, Skin
BTA
Pump, Portable, Aspiration (Manual Or Powered)
BWA
Unit, Electrosurgical And Coagulation, With Accessories
BWN
Table And Attachments, Operating-Room
BWP
Shoe And Shoe Cover, Conductive
FGY
Cannula, Injection
FHM
Apparatus, Suturing, Stomach And Intestinal
FHR
Needle, Gastro-Urology
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
FNW
Pad, Kelly
FQO
Table, Operating-Room, Ac-Powered
FQP
Lamp, Operating-Room
FSE
Table, Operating-Room, Manual
FSH
Tray, Surgical, Needle
FSM
Tray, Surgical, Instrument
FSO
Microscope, Surgical, General & Plastic Surgery
FSP
Loupe, Diagnostic/Surgical
FSQ
Light, Surgical, Instrument
FSS
Light, Surgical, Floor Standing
FST
Light, Surgical, Fiberoptic
FSW
Light, Surgical, Endoscopic
FSX
Light, Surgical, Connector
FSY
Light, Surgical, Ceiling Mounted
FSZ
Light, Surgical, Carrier
FTA
Light, Surgical, Accessories
FTC
Light, Ultraviolet, Dermatological
K
23
3811
DT Controlled Phototherapy Equipment
K
22
3882
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
K
23
0382
3 Series NeoLux
K
23
0076
Enhanced AURORA™ Medical Diode System, and related accessories
K
22
0840
1 Series Phototherapy Equipment
K
21
0004
i8 Tanning Booth
K
21
2510
7 Series Phototherapy Device
K
21
0881
M Series Phototherapy Equipment
K
20
2827
308nm Excimer UV-light Skin Therapy System
K
20
0971
308nm Excimer System
K
19
2411
Psoria-Shield AURORA
K
19
2642
308nm Excimer System
K
19
1571
UV Radiation Treatment System
K
19
1086
Exciplex
K
18
1805
UV Phototherapy
K
18
2215
ClearLink Controlled Phototherapy Equipment
K
17
2273
308nm Excimer System
K
17
3436
Luma Light System
K
17
1702
Exciplex308nm
K
17
0489
Skylit Phototherapy System
K
15
3749
3 Series Phototherapy Unit
K
15
1795
ML24000 UVA-1 Phototherapy Cabinet
K
15
0752
GME ExSys 308
K
15
0912
Houva-NET Control System
K
13
4009
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
K
13
2643
UV PHOTOTHERAPY
K
13
0519
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
K
11
1049
MOBILE VERSA LIGHT
K
11
0912
SMART TOUCH UVTHERAPY MULTIPLE MACHINE
K
11
1172
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
K
10
3204
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
K
10
3708
ML24000 UVA-1 PHOTOTHERAPY UNIT
K
10
3540
PSORIA-LIGHT
K
10
0378
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
K
09
1568
LH-75 PHOTOTHERAPY SYSTEM
K
09
0097
LH-75T PHOTOTHERAPY SYSTEM
K
08
2731
ML24000 UVA-1 PHOTOTHERAPY CABINET
K
07
3503
VERSA LITE
K
07
3587
DERMAPAL WITH DIGITAL TIMER
K
07
3066
308 DERMATOLOGICAL EXCIMER SYSTEM
K
07
2035
RESOLVE UVB PHOTOTHERAPY SYSTEM
K
07
0934
PANOSOL II TRU-BLU, MODEL UBL-417
K
06
3621
3 SERIES PHOTOTHERAPY CABINET
K
06
1589
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
K
06
1295
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
K
05
1330
UVBIOTEK MODELS 3200B AND 4000B
K
05
2660
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO
K
05
0080
CYNOSUREA ECLILITE AND ECLILITE U
K
05
0695
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
K
04
2502
3 SERIES PHOTOTHERAPY CABINET
K
04
1212
HOUVA 3 PHOTOTHERAPY SYSTEM
K
03
3946
LOVELY SYSTEM
K
04
0062
LEVIA PHOTOTHERAPY SYSTEM
K
03
1800
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
K
02
4020
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
K
02
2104
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
K
02
1762
BCLEAR
K
02
2165
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
K
02
1514
PHILIPS PLS9W/12/2P UVB
K
02
1092
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
K
02
0591
BCLEAR
K
01
1197
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
K
98
2082
HANDISOL WOUND HEALING
K
93
5525
PHOTOTHERAPEUTIX MODEL 2480AB
K
93
3954
PHOTOTHERAPEUTIX MODEL 2400B
K
93
3952
PHOTOTHERAPEUTIX MODEL 800B
K
93
3953
PHOTOTHERAPEUTIX MODEL 1650B
K
93
5524
PHOTOTHERAPEUTIX MODEL 3200A
K
93
5526
PHOTOTHERAPEUTIX MODEL 1600B
K
93
5572
SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT
K
93
5840
TL 20W/12/RS & TL 40W/12/RS
K
93
4808
UVISOL AND UVISOL II
K
93
3146
ESB 2400 SEI
K
93
0856
PSORALITE
K
92
4969
PHOTOTHERAPY TIMER
K
92
5171
FREE SUN PRO DESIGN 3000 AND 3800
K
92
4077
HANDISOL
K
92
2963
TL100W/12
K
91
5426
MEDICAL SUNLAMP FOR PHOTOTHERAPY
K
91
3760
PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
K
91
0767
TL100W/01 UVB LAMP
K
90
4427
PANOSOL II UVB-206
K
90
4426
PANOSOL II UVA-218
K
90
4428
PANOSOL II UAB-228
K
90
4425
MODEL 6/01 UV-B FIXTURE
K
90
1324
U.V. SUNLAMP 95UF-II
K
90
0649
FLUORESCENT T12 UVA LAMP
K
90
0693
U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
K
89
6831
ALISUN SUNTANNING BED
K
89
6191
SUNTANNING BED, INC. T12 UVA TANNING LAMPS
K
89
5410
REMINGTON TANFASTIC HANDHELD TANNING WAND
K
88
5026
HOUVA II UVB
K
88
5029
HOUVA II UVA/UVB
K
89
0084
PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
K
88
5184
SHAW SUN SYSTEMS MODEL 2400
K
88
5025
HOUVA II UVA
K
88
3929
TANNING BED
K
88
3952
U. V. SUNLAMP 95UF-11
K
88
2722
HOUVA-BED
K
88
1923
ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72
K
88
1385
PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL
K
87
4889
U.V. SUNLAMP 95 UF-11
K
87
3430
FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12
K
87
2648
SOLAR GOLD UVA SUN TANNING BED
K
87
2651
PANOSOL 2000 624-414
K
87
2650
PANOSOL 2000 624-604
K
87
2649
HAND/FOOT UVA/UVB 624-224
K
87
2707
PANOSOL 2000 624-404
K
87
2706
PANOSOL 2000 624-616
K
87
2605
HAND/FOOT UVA 624-218
K
87
2604
HAND/FOOT 624-208
K
87
1237
SUN CAPSULE I & II SUNTANNING BOOTH
K
87
0167
U.V. SUNLAMP 95UF-11
K
86
4511
PSORALITE 18400 SERIES
K
86
4510
PSORALITE 12800 SERIES
K
86
4546
MAXI-TAN DEVICE
K
86
4907
SUNTANNING LAMP
K
86
4485
SUNFIT SUNLAMP
K
86
3937
OSRAM ULTRAMED 400 W
K
86
3555
BREMI BEAUTY BRONZE
K
86
3518
WEINGART MODEL 1000 SUNLAMP PRODUCT
K
86
2608
SPERTILITE PHOTOTHERAPY LAMP
K
86
2372
ULTRATAN TANNING SYSTEM
K
86
2341
TANNING SOFA
K
86
1963
ULTRALITE HF1236 HAND AND FOOT SYSTEM
K
86
2263
PERSUNAL TAN, MODEL NO. HU-0208L
K
86
2142
SUN-DREAMER SUNTANNING BED
K
86
2097
FACE TANNER
K
86
1989
MODIFICATION OF SUNTANA SUN SYSTEM BED
K
86
1705
CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP)
K
86
1636
MIAMI-SUNNY
K
86
1570
ALPHA TAN 1000 AND ALPHA TAN 1200
K
86
1447
ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900
K
86
1533
SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS
K
86
1107
TAN MATE HOME TANNING UNIT
K
86
1076
RESIDENTIAL TANNING UNIT
K
86
0932
ULTRASUN 1000 & 2000 SUNTANNING UNIT
K
86
0931
ULTRASUN 3000 AND 5000 SUNTANNING UNIT
K
86
0930
ULTRASUN 2500 SUNTANNING UNIT
K
86
0929
ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT
K
86
0859
UVA SUN SYSTEMS
K
86
0856
SILGMANN SOLARIUM SUN-MOBIL MODEL 0918
K
86
0370
SAFE SUN 700 HOME TANNING UNIT
K
86
0567
NORDIC SUN HOME TANNING UNIT
K
86
0566
NORDIC SUN 24 LAMP TANNING BED
K
86
0509
SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE
K
86
0489
EUROTAN BY AYK
K
86
0198
MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING
K
85
4750
TOP SUN
K
86
0347
SUNLAMP MODELS 24N, 30R, 30RE, 37RE
K
86
0144
SUM TAN VI
K
85
5162
ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR
K
86
0117
KRYPTOSOL (SUN LAMP)
K
85
4932
ECUMOL ULTRAVIOLET FACE TANNING UNITS
K
85
4707
SUNTAINNING BOOTH
K
85
4594
PHOENIX U.V.A. SUNTAN BEDS
K
85
4498
SPECTRA 724
K
85
4515
SHAW SUN SYSTEMS 1000, 2000 & 3200
K
85
4020
G-T 1000
K
85
4224
GOLDEN RULE SUN TANNING BEDS
K
85
4170
I.S.M. PRODUCT FAMILY MODEL R3600C
K
85
4154
FOX BED MODEL 2001
K
85
4131
PHASE V-MODEL 1500 RUVA
K
85
4111
EXPRESS TAN SUN CANOPY
K
85
2534
ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
K
85
4171
I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC
K
85
4004
FLUORESCENT T12 UVA TANNING LAMP
K
85
3846
SUN TANNING BED
K
85
3833
TOP SUN MODELS 100,101,103 &139, 139-1, 139-3
K
85
3911
UV-A SUNTANNING EQUIPMENT
K
85
3752
SUN KING
K
85
3679
SUNJET MODELS 240/280
K
85
3692
SUN TANNING BED MODEL EC-3RF
K
85
3587
UVATAN INDUS. UVATAN 900C, 900B/800 & 600C
K
85
3545
FLOURESCENT T12 UVA TANNING LAMP
K
85
3394
600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L
K
85
3248
CHALLENGER SUNRISE
K
85
3177
ECUMOL ULTRAVIOLET SUNTANNNING BEDS
K
85
3046
TAN MODEL I
K
85
2957
SAHARA SUNBED
K
85
2684
WALDMANN F85/100W UV21
K
85
2576
WALDMANN F85/100W UV6
K
85
1408
SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER
K
85
2579
THE SUNTANNING CO. TANNING BED
K
85
2348
PHILIPS SOLARIUM HP 3134
K
85
2243
KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS
K
85
2290
PRIVATAN HOME TANNING CENTER
K
85
2149
PORTASUN MODEL 600/LI SUNLAMP
K
85
2053
ORIGINAL ULTRAVIOLET SUNTANNING LAMP
K
85
1858
FOLD AWAY HUT
K
85
1859
FACIAL/UPPER BODY UNIT
K
84
5029
SURGICAL POWER MAGNET
K
85
1532
SUNTANNING EQUIPMENT
K
85
1536
PHILIPS UV-A SOLARIUM TYPE HP 3141
K
85
1535
PHILIPS UV-A SOLARIUM TYPE HP 3140
K
85
1534
PHILIPS UV-A SOLARIUM TYPE HP 3150
K
85
1533
PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP
K
85
1255
SUN BEDS
K
85
0660
SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY
K
85
0493
SUNSHOWER MODEL HU-01-12L
K
85
0203
PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP
K
85
0204
PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP
K
85
0206
PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP
K
85
0205
PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP
K
84
5001
MARTANIQUE 6-TUBE HOME SOLARIUM
K
85
0042
SOLAR TAN - SOLARIA IV
K
84
5028
MARTANIQUE 7-TUBE RUVA HOME SOLARIUM
K
84
4870
SUNTAN CONNECTIONS BAHAMA SUN-BOOTH
K
84
3902
SOLAR-GOLD UV-A BY EOS
K
84
4039
AZTECH INDUSTRIES SUNTANNING BED AZ100
K
84
3306
UVA SUNTANNING UNITS VARIOUS MODELS
K
84
3814
EMUMOL ULTRAVIOLET SUNTANNING LAMP
K
84
3647
MTI 1200, 401 & 3500
K
84
2975
BROWNIE BOOTH BB1
K
84
2787
SUNBED
K
84
2575
ULTRA-VIOLET A SOURCE LIGHT EMITTING
K
84
2384
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT
K
84
1614
SUN BEDS
K
84
0931
SUN BEDS
K
84
0158
KOSMEDICO GMBH SUNLAMP PRODUCTS
K
84
0132
TANSEEKER
K
84
0133
ULTRAVIOLET TANNING SYSTEMS
K
84
0137
SILGMANN SOLARIUM S-TYPE 1218 COMBO
K
83
4488
MERRITTAN SUN SYSTEM
K
83
3524
SUNBED/SUNROOF TANNING DEVICE
K
83
4495
UV-A SUNTANNING EQUIPMENT 1000-8000
K
83
4493
EVERTAN SUNTAN BEDS
K
83
4492
SALON -BODY TANNING BED
K
83
4491
UVA SUNTANNING LAMPS
K
83
3511
UV-A SUNTANNING EQUIPMENT-SILGMANN
K
83
3490
SILGMANN SOLARIUMS-TYPE 1218 CANOPY &
K
83
3350
KOSMEDICO GMBH SUN LAMP
K
83
3527
UV-A SUN TANNING EQUIPMENT
K
83
3240
INT'L TANNING SYSTEMS B.V
K
83
2794
SUNTANNING BOOTHS AND BEDS
K
82
7890
FOLDALITE UNIT
K
82
0492
SPECTRA305
K
81
2225
METEC HELARIUM LOUNGE & SKY UNITS
K
82
0123
SUNFLOWER
K
81
3307
UVA HEX UNIT
K
81
2663
SOLARIUM COMBINATION
K
81
2446
SUNLAMP
K
81
2579
SUNTANNING HOME UNIT
K
81
2543
TANARAMA
K
81
2521
SUNTANNING DEVICE (SEPAR. FROM K812225)
K
81
1870
UVA SUN TANNING EQUIPMENT
K
81
1585
F72T12/BL-S/HO UVA SUNLAMP
K
81
1586
F72T12/BL-S/SHO-O UVA SUNLAMP
K
81
0796
SUNTAN BOOTH
K
81
1029
SUNLAMP
K
80
3264
SUNLAMP
K
81
0688
THE SUNFACTORY
K
81
0476
B.J.'S UVA SUN TAN BED W/SUN ROOF
K
80
1017
TANIT COMMERCIAL SUNTAN BOOTH
K
80
0950
TANIT HOME SUNTANNING UNIT
K
80
0160
SUN-TANNING BOOTHS
K
79
2500
UVB LIGHT BOX - UVB LIGHT BOOTH
K
79
0167
SUNLAMP
K
77
0862
BLACK LAMPS,F72T12/BL/HO
K
76
1179
PSORALITE
K
76
1186
HOUVA-LITE ARM UNIT #601
K
76
1189
HOUVA-LITE SOLE UNIT #502
K
76
1188
HOUVA-LITE PALM UNIT #501
K
76
1187
HOUVA-LITE LEG UNIT #701
K
76
0471
LAMP, FLOURESCENT BLACK, HIGH OUTPUT
K
76
0482
SUNLAMP (F40-UVB & F20-UVB)
FTD
Lamp, Surgical
FTF
Illuminator, Non-Remote
FTG
Illuminator, Remote
FTH
Camera, Still, Microsurgical
FTS
Camera, Cine, Endoscopic, With Audio
FTT
Camera, Still, Surgical
FTX
Mirror, General & Plastic Surgery
FTY
Tape, Measuring, Rulers And Calipers
FWB
Camera, Television, Surgical, Without Audio
FWC
Camera, Television, Surgical, With Audio
FWD
Camera, Television, Microsurgical, Without Audio
FWE
Camera, Television, Microsurgical, With Audio
FWF
Camera, Television, Endoscopic, Without Audio
FWG
Camera, Television, Endoscopic, With Audio
FWH
Camera, Cine, Surgical, Without Audio
FWI
Camera, Cine, Surgical, With Audio
FWJ
Camera, Cine, Microsurgical, Without Audio
FWK
Camera, Cine, Microsurgical, With Audio
FWL
Camera, Cine, Endoscopic, Without Audio
FWW
Table, Operating-Room, Pneumatic
FWX
Table, Operating-Room, Mechanical
FWY
Table, Operating-Room, Non-Electrical
FWZ
Operating Room Accessories Table Tray
FXM
Camera, Still, Endoscopic
FXN
Tape, Camera, Surgical
FXQ
Lens, Camera, Surgical
FXR
Holder, Camera, Surgical
FXS
Frame, Camera, Surgical
FXT
Film, Camera, Surgical
FXW
Shoes, Operating-Room
FYE
Dress, Surgical
FYF
Cap, Surgical
FZK
Chair, Surgical, Non-Electrical
FZM
Stool, Operating-Room
FZO
Chisel, Surgical, Manual
FZP
Clip, Implantable
FZQ
Clip, Removable (Skin)
FZR
Contractor, Surgical
FZS
Curette, Surgical, General Use
FZT
Cutter, Surgical
FZW
Expander, Surgical, Skin Graft
FZX
Guide, Surgical, Instrument
FZY
Hammer, Surgical
FZZ
Marker, Skin
GAA
Needle, Aspiration And Injection, Disposable
GAB
Needle, Suturing, Disposable
GAC
Rasp, Surgical, General & Plastic Surgery
GAD
Retractor
GAE
Snare, Surgical
GAF
Spatula, Surgical, General & Plastic Surgery
GAH
Stylet, Surgical, General & Plastic Surgery
GAI
Stripper, Vein, Reusable
GAJ
Stripper, Vein, Disposable
GAK
Suture, Absorbable
GAL
Suture, Absorbable, Natural
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
GAN
Suture, Absorbable, Synthetic
GAO
Suture, Nonabsorbable
GAP
Suture, Nonabsorbable, Silk
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
GAS
Suture, Nonabsorbable, Synthetic, Polyester
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
GBA
Catheter, Balloon Type
GBB
Chair, Surgical, Ac-Powered
GBC
Lamp, Surgical, Incandescent
GBN
Catheter, Pediatric, General & Plastic Surgery
GBO
Catheter, Nephrostomy, General & Plastic Surgery
GBP
Catheter, Multiple Lumen
GBQ
Catheter, Continuous Irrigation
GBS
Catheter, Ventricular, General & Plastic Surgery
GBW
Catheter, Peritoneal
GBX
Catheter, Irrigation
GBY
Catheter, Eustachian, General & Plastic Surgery
GBZ
Catheter, Cholangiography
GCB
Needle, Catheter
GCC
Dilator, Catheter
GCD
Connector, Catheter
GCE
Adaptor, Catheter
GCY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
GCZ
Retainer, Surgical
GDC
Table, Operating-Room, Electrical
GDF
Guide, Needle, Surgical
GDG
Hook, Surgical, General & Plastic Surgery
GDH
Gouge, Surgical, General & Plastic Surgery
GDI
Dissector, Surgical, General & Plastic Surgery
GDJ
Clamp, Surgical, General & Plastic Surgery
GDL
Needle, Suturing, Reusable
GDM
Needle, Aspiration And Injection, Reusable
GDN
Knife, Amputation
GDO
Applier, Surgical, Clip
GDR
Saw, Manual And Accessories
GDT
Staple, Removable (Skin)
GDW
Staple, Implantable
GDX
Scalpel, One-Piece
GDY
Gauze/Sponge, Internal, X-Ray Detectable
GDZ
Handle, Scalpel
GEA
Cannula, Surgical, General & Plastic Surgery
GEC
Brush, Scrub, Operating-Room
GED
Brush, Dermabrasion, Manual
GEE
Brush, Biopsy, General & Plastic Surgery
GEF
Applier, Staple, Surgical,
GEG
Elevator, Surgical, General & Plastic Surgery
GEH
Unit, Cryosurgical, Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
GEJ
Carrier, Ligature
GEN
Forceps, General & Plastic Surgery
GEO
File, Surgical, General & Plastic Surgery
GES
Blade, Scalpel
GET
Motor, Surgical Instrument, Pneumatic Powered
GEX
Powered Laser Surgical Instrument
GEY
Motor, Surgical Instrument, Ac-Powered
GFA
Blade, Saw, General & Plastic Surgery, Surgical
GFB
Head, Surgical, Hammer
GFC
Driver, Surgical, Pin
GFD
Dermatome
GFE
Brush, Dermabrasion, Powered
GFF
Bur, Surgical, General & Plastic Surgery
GFG
Bit, Surgical
GFI
Osteotome, Manual
GFJ
Mallet, Surgical, General & Plastic Surgery
HAB
Saw, Powered, And Accessories
HAM
Apparatus, Electrosurgical
HBI
Illuminator, Fiberoptic, Surgical Field
HBT
Applier, Hemostatic Clip
HCF
Instrument, Ligature Passing And Knot Tying
HJE
Lamp, Fluorescein, Ac-Powered
HMP
Pad, Eye
HRB
Microscope, Operating, Non-Electric, Ophthalmic
HRM
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
HRQ
Hemostat
HSO
Saw
HTC
Pliers, Surgical
HTD
Forceps
HTE
Elevator
HTF
Curette
HTR
Rasp
HTZ
Instrument, Cutting, Orthopedic
HWM
Osteotome
HXD
Clamp
HXL
Mallet
HXR
Spatula, Orthopedic
HXT
Tape, Orthopedic
HYA
Forceps, Wire Holding
JCX
Apparatus, Suction, Ward Use, Portable, Ac-Powered
JCY
Catheter, Infusion
JEA
Table, Surgical With Orthopedic Accessories, Ac-Powered
JEB
Table, Surgical With Orthopedic Accessories, Manual
JOS
Electrode, Electrosurgical
JOT
Electrode, Gel, Electrosurgical
JYC
Cannula, Ear
JYD
Chisel, Mastoid
KAM
Cannula, Sinus
KAN
Chisel, Nasal
KCE
Cannulae, Bronchial
KDC
Instrument, Surgical, Disposable
KDD
Kit, Surgical Instrument, Disposable
KDG
Chisel (Osteotome)
KFK
Saw, Pneumatically Powered
KGL
Cabinet, Phototherapy (Puva)
KGS
Retention Device, Suture
KGW
Ring (Wound Protector), Drape Retention, Internal
KGY
Bag, Intestine
KGZ
Accessories, Catheter
KIK
Hook, Bone
KOX
Solvent, Adhesive Tape
KOY
Degreaser, Skin, Surgical
KOZ
Beads, Hydrophilic, For Wound Exudate Absorption
KQM
Camera, Surgical And Accessories
LEJ
Booth, Sun Tan
LMF
Agent, Absorbable Hemostatic, Collagen Based
LMG
Agent, Absorbable Hemostatic, Non-Collagen Based
LRO
General Surgery Tray
LRP
Tray, Surgical
LRW
Scissors, General, Surgical
LRY
Punch, Surgical
LRZ
Screwdriver, Surgical
LSA
Vise, Bench, Surgical
LWG
Surgical Table Cushion
LWK
Razor, Surgical
LXK
Scrapper, Skin Specimen
LXZ
Guard, Instrument
LYV
Label Or Tag, Sterile
LZM
Guard, Skin Graft
MCH
Clip, Hemostatic
MCZ
Suture Removal Kit
MDA
Elastomer, Silicone, For Scar Management
MDM
Instrument, Manual, Surgical, General Use
MGO
Closure, Wound, Adhesive
MIJ
Needle, Tumor Localization
MJG
Device, Percutaneous, Biopsy
MKY
System, Skin Closure
MOQ
Battery, Replacement, Rechargeable
MPN
Tissue Adhesive For The Topical Approximation Of Skin
MUL
Generator, Electrosurgical, Coagulation, Cancer
MUU
System, Suction, Lipoplasty
MVR
Device, Anastomotic, Microvascular
MWY
System, Microwave, Hair Removal
MXG
Lamp, Uvc, (For Treating Skin And Wounds)
MXW
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
NAB
Gauze / Sponge,Nonresorbable For External Use
NAC
Dressing, Wound, Hydrophilic
NAD
Dressing, Wound, Occlusive
NAE
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
NCA
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
NEH
Anchor, Fascial
NEU
Marker, Radiographic, Implantable
NEW
Suture, Surgical, Absorbable, Polydioxanone
NEY
System, Ablation, Microwave And Accessories
NJC
Clip, Vas Deferens
NJU
Suture, Nonabsorbable, Nitinol
NJZ
Extractor, Vein
NLK
Needle, Biopsy, Cardiovascular, Reprocessed
NLL
Staple, Implantable, Reprocessed
NMJ
Clip, Implantable, Reprocessed
NMT
Needle, Catheter, Reprocessed
NMU
Needle, Gastro-Urology, Reprocessed
NNA
Biopsy Device, Percutaneous, Reprocessed
NNC
Needle, Aspiration And Needle, Reprocessed
NRB
Wound Cleaner, Ultrasound
NRJ
Ultrasound, Skin Permeation
NTB
System, Ablation, Ultrasound And Accessories
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
NUV
Massager, Vacuum, Light Induced Heating
NVH
Suture, Knot, Mechanical
NVJ
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
NWF
Drill, Battery Powered, Subungual Hematoma
NWJ
Suture, Recombinant Technology
NXF
Gas, Laser Generating
NYS
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
OAB
Low Energy Direct Current Thermal Ablation System
ODR
Electrosurgical Patient Return Electrode
OEI
Drainage Catheter With Antibiotic
OEL
Laser, Benign Prostatic Hyperplasia
OHO
First Aid Kit Without Drug
OHS
Light Based Over The Counter Wrinkle Reduction
OHT
Light Based Over-The-Counter Hair Removal
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
OJJ
Burn Kit Without Drug
OJR
Vacuum Powered Body Fluid Collection Kit
OJT
Aspiration Tray
OJU
Skin Prep Tray
OJV
Single Use Instrument Tray
OUH
Skin Resurfacing Rf Applicator
OUP
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
OJW
Shave Prep Kit
OKJ
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
OKO
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
OLP
Over-The-Counter Powered Light Based Laser For Acne
OMD
Cutaneous Tissue Adhesive With Mesh
OMP
Negative Pressure Wound Therapy Powered Suction Pump
ONE
Powered Light Based Non-Laser Surgical Instrument
ONF
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
ONG
Powered Laser Surgical Instrument With Microbeam\Fractional Output
ONQ
Electrosurgical Coagulation For Aesthetic
OOK
Dermal Cooling Pack/Vacuum/Massager
ORE
Cryogenic, Skin Tag Removal, Otc
ORK
Laser Assisted Lipolysis
OTK
Wound Drain Catheter System
OUB
Instrument For Treatment Of Hyperhidrosis
OVN
Suture Kit
OXT
Percutaneous Surgical Set With Attachments
OYW
Laser, Cellulite Appearance
PAY
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
PBX
Massager, Vacuum, Radio Frequency Induced Heat
PBY
Temporary Tissue Marker
PDG
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
PDW
Internal Tissue Marker
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
PFP
Silicone Hydrogel For Scar Management
PGZ
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
PJK
Tissue Adhesive For Internal Use
PKD
Laceration Tray
PKE
Laparoscopic Cholecystectomy Kit
PKO
Transparent Patch For Use In Treatment Of Tattoos
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
PMC
Scalp Cooling System
PMX
Absorbable Collagen Hemostatic Agent With Thrombin
PNL
Magnetic Surgical System
POD
Temporary, Internal Use Hemostatic
PQI
Wound Retraction And Protection System
PSN
Light Based Imaging
PTX
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
PUI
Drape, Surgical, Exempt
PXN
Basic Set-Up Tray
PXO
Bone Marrow Biopsy Tray
PXP
Breast Biopsy / Localization Tray
QRL
Multiple Use Blood Lancet For Single Patient Use Only
PXQ
Burn Dressing Tray
PXR
Cement And Bone Removal Kit
PXS
Cholecystectomy Kit
PXU
Fluid Drainage Tray
PXV
General Purpose Instrument Tray
PXW
Herniorraphy Kit
PXX
Incision Tray
PXY
Irrigation Kit (Wounds)
PXZ
Laparascopic Sphincterotomy Kit
PYA
Liver Biopsy Kit
PYB
Minor Surgical Procedures Tray
PYC
Paracentesis Tray
PYD
Pelviscopy Kit
PYE
Staple Removal Kit
PYF
Sterile Puncture Tray
PYG
Suction Catheter Kit
PYH
Surgical Retractor Kit
PYI
Thoracic Catheter Insertion Tray
PYJ
Ulcer Wound Tray
PYK
Venous Ulcer Kit
PYL
Wound Drainage Kit
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
PZQ
General Laparoscopic Power Morcellation Containment System
QAI
Powered Microneedle Device
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
QCR
Wound Autofluorescence Imaging Device
QCY
Laser Absorbing Particles
QDF
Parathyroid Autofluorescence Detection Device
QDG
Parathyroid Autofluorescence Imaging Device
QRM
Multiple Use Blood Lancet For Multiple Patient Use
QFC
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
QHF
Energy Based Device For Treatment Of Tattoos
QJF
Autofluorescence Imaging Adjunct Tool For Wounds
QKL
Lipoaspirate Washing System For Aesthetic Body Contouring
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
QPB
System, Suction, Lipoplasty For Removal
QPX
Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
QPZ
Contact Cooling For Skin Lesion Pain Relief
RAB
Sunlamp Products (Pre-Standard)
REF
Suntan Bed
REG
Suntan Lamp
REH
Tabletop Sunlamp System
QUB
Suction Lipoplasty System For Removal And Transfer
QVJ
Low Power Electrosurgical Devices For Skin Lesion Destruction
QZN
Multi-Photon Imaging
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-e—surgical-devices
/
FTC
/
K073066
View Source
308 DERMATOLOGICAL EXCIMER SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K073066
510(k) Type
Traditional
Applicant
QUANTEL MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/26/2007
Days to Decision
57 days
Submission Type
Summary