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Innolitics
Anesthesiology
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Ophthalmic
Review Panel
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
HLD
Engine, Trephine, Accessories, Gas-Powered
1
Product Code
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
2
Product Code
FCT
Headlight, Fiberoptic Focusing
2
Product Code
FSR
Light, Headband, Surgical
2
Product Code
FTZ
Locator, Magnetic
1
Product Code
HMQ
Marker, Sclera
1
Product Code
HMR
Marker, Ocular
1
Product Code
HMS
Drum, Eye Knife Test
1
Product Code
HMX
Cannula, Ophthalmic
1
Product Code
HMY
Keratome, Battery-Powered
1
Product Code
HMZ
Trabeculotome
1
Product Code
HNA
Spud, Ophthalmic
1
Product Code
HNB
Spoon, Ophthalmic
1
Product Code
HNC
Specula, Ophthalmic
1
Product Code
HND
Spatula, Ophthalmic
1
Product Code
HNE
Snare, Enucleating
1
Product Code
HNF
Scissors, Ophthalmic
1
Product Code
HNG
Rongeur, Lachrymal Sac
1
Product Code
HNH
Ring, Ophthalmic (Flieringa)
1
Product Code
HNI
Retractor, Ophthalmic
1
Product Code
HNJ
Punch, Corneo-Scleral
1
Product Code
HNK
Probe, Trabeculotomy
1
Product Code
HNL
Probe, Lachrymal
1
Product Code
HNM
Needle, Ophthalmic Suturing
1
Product Code
HNN
Knife, Ophthalmic
1
Product Code
HNO
Keratome, Ac-Powered
1
Product Code
HNP
Introducer, Sphere
1
Product Code
HNQ
Hook, Ophthalmic
1
Product Code
HNR
Forceps, Ophthalmic
1
Product Code
HNS
Expressor
1
Product Code
HNT
Erisophake
1
Product Code
HNW
Dilator, Lachrymal
1
Product Code
HNX
Depressor, Orbital
1
Product Code
HNY
Cystotome
1
Product Code
HNZ
Curette, Ophthalmic
1
Product Code
HOA
Compressor, Orbital
1
Product Code
HOB
Clamp, Muscle, Ophthalmic
1
Product Code
HOC
Clip, Iris Retractor
1
Product Code
HOD
Clamp, Eyelid, Ophthalmic
1
Product Code
HOE
Caliper, Ophthalmic
1
Product Code
HOF
Burr, Corneal, Manual
1
Product Code
HOG
Burr, Corneal, Battery-Powered
1
Product Code
HOH
Spectacle, Operating (Loupe), Ophthalmic
1
Product Code
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
1
Product Code
HOZ
Sponge, Ophthalmic
2
Product Code
HPM
Locator, Metal, Electronic
2
Product Code
HPN
Magnet, Permanent
1
Product Code
HPO
Magnet, Ac-Powered
2
Product Code
HPP
Headlamp, Operating, Battery-Operated
1
Product Code
HPQ
Headlamp, Operating, Ac-Powered
2
Product Code
HPS
Unit, Cryophthalmic
2
Product Code
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
1
Product Code
HQA
Unit, Cryotherapy, Ophthalmic
2
Product Code
HQB
Photocoagulator And Accessories
2
Product Code
HQC
Unit, Phacofragmentation
2
Product Code
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
2
Product Code
HQF
Laser, Ophthalmic
2
Product Code
K
22
0430
Capsulo
2
Cleared 510(K)
K
21
3592
Iridex 810 Laser
2
Cleared 510(K)
K
21
2630
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
2
Cleared 510(K)
K
20
3130
Ophthalmic Yag Laser System YC-200
2
Cleared 510(K)
K
20
2760
Iridex 810 Laser
2
Cleared 510(K)
K
20
1623
LION Photocoagulator
2
Cleared 510(K)
K
20
1502
Vitra 810
2
Cleared 510(K)
K
19
2045
Ophthalmic Yag Laser System YC-200
2
Cleared 510(K)
K
19
0448
LightLas Pattern Scanning System - TruScan Pro
2
Cleared 510(K)
K
19
0083
Leaf Photocoagulator
2
Cleared 510(K)
K
18
1682
VISULAS green
2
Cleared 510(K)
K
18
0402
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
2
Cleared 510(K)
K
17
1488
PSLT for PASCAL Streamline
2
Cleared 510(K)
K
17
0067
Easyret
2
Cleared 510(K)
K
17
0302
YELLOW LASER PHOTOCOAGULATOR YLC-500
2
Cleared 510(K)
K
15
3769
R:GEN Laser System
2
Cleared 510(K)
K
15
2688
LightLas Multi-Wavelength Medical Laser System
2
Cleared 510(K)
K
15
2603
Green Laser Photocoagulator GYC-500
2
Cleared 510(K)
K
14
2398
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
2
Cleared 510(K)
K
14
2830
Ophthalmed Bending Laser Probes
2
Cleared 510(K)
K
14
2172
LIGHTMED TRUSCAN 577
2
Cleared 510(K)
K
13
3019
FIBERION OPHTHALMIC ENDOLASER PROBE
2
Cleared 510(K)
K
14
0362
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
2
Cleared 510(K)
K
13
3358
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
2
Cleared 510(K)
K
14
0336
OPTIMUS FUSION: SLT, YAG AND YAG/SLT
2
Cleared 510(K)
K
13
0195
SCANNING LASERLINK
2
Cleared 510(K)
K
13
1207
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
2
Cleared 510(K)
K
12
4043
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
2
Cleared 510(K)
K
13
0933
SOLUTIS
2
Cleared 510(K)
K
12
2202
ELLEX 2RT
2
Cleared 510(K)
K
12
3542
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
2
Cleared 510(K)
K
12
3056
PASCAL LASER INDIRECT OPHTHALMOSCOPE
2
Cleared 510(K)
K
12
1187
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
2
Cleared 510(K)
K
12
0825
SUPRA SCAN DELIVERY SYSTEM
2
Cleared 510(K)
K
11
1460
OPTO HYALUS GREEN LASER
2
Cleared 510(K)
K
11
2154
FEMTO LDV
2
Cleared 510(K)
K
11
1643
OPTO MITRA YELLOW LASER
2
Cleared 510(K)
K
10
3547
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
2
Cleared 510(K)
K
11
1108
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
2
Cleared 510(K)
K
10
3056
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
2
Cleared 510(K)
K
10
0253
VISUMAX LASER KERATOME
2
Cleared 510(K)
K
10
0019
PASCAL STREAMLINE PHOTOCOAGULATOR
2
Cleared 510(K)
K
09
1064
NAVILAS LASER SYSTEM
2
Cleared 510(K)
K
09
1981
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
2
Cleared 510(K)
K
09
2621
PASCAL STREAMLINE PHOTOCOAGULATOR
2
Cleared 510(K)
K
09
1534
LIGHTLAS MODEL 532
2
Cleared 510(K)
K
09
0774
LIGHTLAS SELECTOR
2
Cleared 510(K)
K
09
1581
SUPRA 577.Y LASER
2
Cleared 510(K)
K
08
1946
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
08
1774
SOLX 790 TITANIUM SAPPHIRE LASER
2
Cleared 510(K)
K
08
1565
INTEGRE PRO, MODEL L2RY
2
Cleared 510(K)
K
08
0423
INTEGRE, MODEL LP581
2
Cleared 510(K)
K
07
2823
MERILAS 532A
2
Cleared 510(K)
K
06
2624
NEXT GENERATION LASER
2
Cleared 510(K)
K
06
3297
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
2
Cleared 510(K)
K
07
0776
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
06
2074
IRIDEX WIRELESS FOOTSWITCH
2
Cleared 510(K)
K
06
1024
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
2
Cleared 510(K)
K
05
1944
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
2
Cleared 510(K)
K
05
0807
20G SMA LASER FIBER, MODEL LF100
2
Cleared 510(K)
K
05
0541
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
2
Cleared 510(K)
K
04
3613
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
2
Cleared 510(K)
K
04
3236
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
2
Cleared 510(K)
K
04
1598
LASEREX, MODEL LP4532
2
Cleared 510(K)
K
04
0209
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
2
Cleared 510(K)
K
03
3941
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
2
Cleared 510(K)
K
03
1665
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
2
Cleared 510(K)
K
03
1023
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
2
Cleared 510(K)
K
02
3094
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
2
Cleared 510(K)
K
02
1538
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
2
Cleared 510(K)
P
99
0078
HYPERION LTK SYSTEM
2
PMA Approval
K
02
0374
OCULIGHT SL/SLX
2
Cleared 510(K)
K
01
3760
DC-3300 LASER DIODE PHOTOCOAGULATOR
2
Cleared 510(K)
K
01
0372
LIGHTLAS 532 PHOTOCOAGULATOR
2
Cleared 510(K)
P
99
0078
SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)
2
PMA Approval
P
99
0078
HYPERION LTK SYSTEM
2
PMA Approval
K
00
1772
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
2
Cleared 510(K)
K
99
0665
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
2
Cleared 510(K)
K
99
0075
LPULSA SYL-9000 OPHTHALMIC YAG LASER
2
Cleared 510(K)
K
98
1196
MEDITEC LINK
2
Cleared 510(K)
K
97
3193
LUXSCOPE
2
Cleared 510(K)
K
97
3220
RODENSTOCK LASER SLITLAMP
2
Cleared 510(K)
K
97
2514
LASEREX LP1532 PHOTOCOAGULATOR
2
Cleared 510(K)
K
97
1950
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
2
Cleared 510(K)
K
96
4751
CERALAS DIODE LASER SYSTEM (CERALAS D2)
2
Cleared 510(K)
K
96
0971
OCULIGHT GL
2
Cleared 510(K)
K
96
0522
DIOPEXY PROBE
2
Cleared 510(K)
K
95
1079
NIDEK MODEL GYC-1500 AND GYC-2000
2
Cleared 510(K)
K
95
2894
VISULINK 900 ARGON
2
Cleared 510(K)
K
94
2180
KEELER MULTILASE 3000
2
Cleared 510(K)
K
93
5747
MEGABEAM ENDOCULAR PROBE
2
Cleared 510(K)
K
93
1784
HGM ILLUMINATING IMAGING ENDOCULAR PROBE
2
Cleared 510(K)
K
93
2836
NIDEK MODEL AC-2300
2
Cleared 510(K)
K
93
2296
JR -- OPHTHALMIC ARGON LASER
2
Cleared 510(K)
K
92
5663
HGM ASPIRATING ENDOOCULAR(TM) PROBE
2
Cleared 510(K)
K
92
6470
LASER AND EMPHASIS SCLEROSTOMY TIP
2
Cleared 510(K)
K
91
0532
URAM OPHTHALMIC LASER ENDOSCOPE
2
Cleared 510(K)
K
91
0805
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
2
Cleared 510(K)
K
90
4699
COMPAC(TM) DIODE LASERS
2
Cleared 510(K)
K
90
5453
CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND
2
Cleared 510(K)
K
91
0612
CANDELA DIODE TRABECULOPLASTY LASER DTL
2
Cleared 510(K)
K
90
5141
CENTAURI
2
Cleared 510(K)
K
90
3421
TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
2
Cleared 510(K)
K
90
4366
CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
90
0199
LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY
2
Cleared 510(K)
K
89
5213
MICROLASE BY LASER TRABECULOPLASTY
2
Cleared 510(K)
K
89
5196
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
89
4835
LASERMED* GOGGLES AND SPECTACLES
2
Cleared 510(K)
K
89
4273
NIDEK MODEL AKC-8000
2
Cleared 510(K)
K
89
3630
CANDELA UPC LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
89
3709
COHERENT MARIE ARGON PHOTOCOAGULATOR
2
Cleared 510(K)
K
89
0509
INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
2
Cleared 510(K)
K
89
0086
MICROLASE 8 0 0 (OPHTHALMIC LASER)
2
Cleared 510(K)
K
88
5164
LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM
2
Cleared 510(K)
K
88
2908
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
2
Cleared 510(K)
K
88
3213
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
2
Cleared 510(K)
K
88
1494
FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER
2
Cleared 510(K)
K
88
2372
RESUBMITTED DIODE LASER COAGULATOR
2
Cleared 510(K)
K
88
1134
SLT CONTACT LASER SYSTEM OCULOPLASTICS
2
Cleared 510(K)
K
87
5000
PRISMA DISPOSABLE ENDO-OCULAR PROBE
2
Cleared 510(K)
K
87
4609
ZEISS VISULAS ARGON LASER
2
Cleared 510(K)
K
87
3460
OPHTHALAS DYE OPHTHALMIC LASER
2
Cleared 510(K)
K
87
2846
NIDEK ADC-8000 LASER SYSTEM
2
Cleared 510(K)
K
87
0839
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
2
Cleared 510(K)
K
86
4063
ORION 3001, LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
86
3246
MIRALITE
2
Cleared 510(K)
K
86
3591
ENDOPHOTOCOAGULATION PROBE
2
Cleared 510(K)
K
86
2568
LDS - LASER DELIVERY SYSTEM
2
Cleared 510(K)
K
86
2987
MODEL 1000 OPHTHALMIC LASER SYSTEM
2
Cleared 510(K)
K
86
0358
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)
2
Cleared 510(K)
K
85
4949
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
2
Cleared 510(K)
K
85
4288
OPHALMIC LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
85
3890
OPHTHALMIC LASER PHOTOCOAGULATOR
2
Cleared 510(K)
K
85
2529
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
2
Cleared 510(K)
K
85
2234
MDS 83 OPHTHALMIC DYE LASER SYSTEM
2
Cleared 510(K)
K
85
2464
HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
2
Cleared 510(K)
K
84
4357
SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR
2
Cleared 510(K)
K
85
0572
HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K
2
Cleared 510(K)
K
84
4668
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
2
Cleared 510(K)
K
84
4358
SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
2
Cleared 510(K)
K
84
3965
ARGON LASER PHOTOCOAGULATOR SYS
2
Cleared 510(K)
K
84
2251
AMERI. MEDICAL OPTICS ARGON LASER PHOTO
2
Cleared 510(K)
K
84
2250
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE
2
Cleared 510(K)
K
84
2412
MODEL 4000 MD-YAG LASER FOR MALIGNANT
2
Cleared 510(K)
K
84
1855
AMER. MED. OPTICS ARGON LASER PHOTO
2
Cleared 510(K)
K
84
1856
AMER. MED. OPTICS ARGON/KRYPTON LASER
2
Cleared 510(K)
K
84
0590
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
2
Cleared 510(K)
K
84
0145
MONITOR CO2 LASER SURGICAL SYSTEM
2
Cleared 510(K)
K
83
4610
LASER LENS-VARIOUS MODELS
2
Cleared 510(K)
K
84
0854
MEDICAL LASER ENDOCOAGULATOR 5K
2
Cleared 510(K)
K
83
4305
ARGON/KRYPTON ION LASER PHOTOCOAGULA
2
Cleared 510(K)
K
83
4060
RELIANCE OPHTHALMIC SLIT LAMP R-083
2
Cleared 510(K)
K
83
3532
OCULASE 514 OPHTHALMIC ARGON LASER
2
Cleared 510(K)
K
83
3533
LASER PHOTOCOAGULATOR 1520-A & K
2
Cleared 510(K)
K
83
2316
OPHTHALMIC ARGON LASER #700A
2
Cleared 510(K)
K
83
2089
MODEL 150K LASER COAGULATOR
2
Cleared 510(K)
K
83
3232
LASER PROTECTIVE EYESHIELD
2
Cleared 510(K)
K
83
3274
DERMATOLOGY HANDPIECE-OPHTH LASER
2
Cleared 510(K)
K
81
3492
BRITT KRYPTON LASERS 150K & 152K
2
Cleared 510(K)
K
81
2219
MODEL 900S INTRAOCULAR PROBE
2
Cleared 510(K)
K
80
1336
MODEL 900K PHOTOCOAGULATOR
2
Cleared 510(K)
K
79
1659
MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL
2
Cleared 510(K)
K
78
2106
COAGULATOR, MODEL 40 AARGON
2
Cleared 510(K)
K
78
1965
LASER COAGULATOR, MODEL 41AK
2
Cleared 510(K)
K
78
2065
LASER, PHOTOCOAGULATION
2
Cleared 510(K)
HQO
Unit, Cautery, Thermal, Ac-Powered
2
Product Code
HQP
Unit, Cautery, Thermal, Battery-Powered
2
Product Code
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
2
Product Code
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
2
Product Code
HQS
Burr, Corneal, Ac-Powered
1
Product Code
HRF
Engine, Trephine, Accessories, Battery-Powered
1
Product Code
HRG
Engine, Trephine, Accessories, Ac-Powered
1
Product Code
HRH
Trephine, Manual, Ophthalmic
1
Product Code
HRJ
Table, Instrument, Powered, Ophthalmic
1
Product Code
HRK
Table, Instrument, Manual, Ophthalmic
1
Product Code
HRN
Unit, Cryophthalmic, Ac-Powered
2
Product Code
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
2
Product Code
HRP
Pen, Marking, Surgical
1
Product Code
KYB
Lens, Guide, Intraocular
1
Product Code
KYG
Device, Irrigation, Ocular Surgery
1
Product Code
LCC
Applicator, Ocular Pressure
2
Product Code
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
3
Product Code
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
2
Product Code
LWL
Fluid, Intraocular
3
Product Code
LXP
Plug, Scleral
2
Product Code
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
2
Product Code
LZP
Aid, Surgical, Viscoelastic
3
Product Code
MLZ
Vitrectomy, Instrument Cutter
2
Product Code
MMC
Dilator, Expansive Iris (Accessory)
2
Product Code
MOE
Collagen Corneal Shield
1
Product Code
MSR
Tubing, Replacement, Phacofragmentation Unit
2
Product Code
MSS
Folders And Injectors, Intraocular Lens (Iol)
1
Product Code
MUS
Fluidic, Phacoemulsification/Phacofragmentation
2
Product Code
MXO
Laser, System, Phacolysis
2
Product Code
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
1
Product Code
MYD
Keratome, Water Jet
1
Product Code
NCE
Injector, Capsular Tension Ring
1
Product Code
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
2
Product Code
NGY
Cannula, Trocar, Ophthalmic
1
Product Code
NKX
Needle, Phacoemulsification, Reprocessed
2
Product Code
NKY
Blade, Keratome, Reprocessed
1
Product Code
NLA
Knife, Ophthalmic, Reprocessed
1
Product Code
NVB
Intraocular, Pressure Measuring Device
3
Product Code
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
1
Product Code
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
1
Product Code
OJK
Eye Tray
2
Product Code
OOE
Ophthalmic Femtosecond Laser
2
Product Code
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
1
Product Code
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
2
Product Code
PZG
Surgical Eye Tray
1
Product Code
QDV
Iol Tray
1
Product Code
QDW
Phaco Kit
2
Product Code
QDY
Vitrectomy Kit
2
Product Code
QGJ
Corneal Inlay Inserter Handle
1
Product Code
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
1
Product Code
PYU
Sponge, Eyelid Cleaning, Powered
1
Product Code
Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
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surgical-devices
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HQF
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K910805
View Source
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910805
510(k) Type
Traditional
Applicant
HERAEUS LASERSONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/1991
Days to Decision
87 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
Surgical Devices
HLD
Engine, Trephine, Accessories, Gas-Powered
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
FCT
Headlight, Fiberoptic Focusing
FSR
Light, Headband, Surgical
FTZ
Locator, Magnetic
HMQ
Marker, Sclera
HMR
Marker, Ocular
HMS
Drum, Eye Knife Test
HMX
Cannula, Ophthalmic
HMY
Keratome, Battery-Powered
HMZ
Trabeculotome
HNA
Spud, Ophthalmic
HNB
Spoon, Ophthalmic
HNC
Specula, Ophthalmic
HND
Spatula, Ophthalmic
HNE
Snare, Enucleating
HNF
Scissors, Ophthalmic
HNG
Rongeur, Lachrymal Sac
HNH
Ring, Ophthalmic (Flieringa)
HNI
Retractor, Ophthalmic
HNJ
Punch, Corneo-Scleral
HNK
Probe, Trabeculotomy
HNL
Probe, Lachrymal
HNM
Needle, Ophthalmic Suturing
HNN
Knife, Ophthalmic
HNO
Keratome, Ac-Powered
HNP
Introducer, Sphere
HNQ
Hook, Ophthalmic
HNR
Forceps, Ophthalmic
HNS
Expressor
HNT
Erisophake
HNW
Dilator, Lachrymal
HNX
Depressor, Orbital
HNY
Cystotome
HNZ
Curette, Ophthalmic
HOA
Compressor, Orbital
HOB
Clamp, Muscle, Ophthalmic
HOC
Clip, Iris Retractor
HOD
Clamp, Eyelid, Ophthalmic
HOE
Caliper, Ophthalmic
HOF
Burr, Corneal, Manual
HOG
Burr, Corneal, Battery-Powered
HOH
Spectacle, Operating (Loupe), Ophthalmic
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
HOZ
Sponge, Ophthalmic
HPM
Locator, Metal, Electronic
HPN
Magnet, Permanent
HPO
Magnet, Ac-Powered
HPP
Headlamp, Operating, Battery-Operated
HPQ
Headlamp, Operating, Ac-Powered
HPS
Unit, Cryophthalmic
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
HQA
Unit, Cryotherapy, Ophthalmic
HQB
Photocoagulator And Accessories
HQC
Unit, Phacofragmentation
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
HQF
Laser, Ophthalmic
K
22
0430
Capsulo
K
21
3592
Iridex 810 Laser
K
21
2630
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
K
20
3130
Ophthalmic Yag Laser System YC-200
K
20
2760
Iridex 810 Laser
K
20
1623
LION Photocoagulator
K
20
1502
Vitra 810
K
19
2045
Ophthalmic Yag Laser System YC-200
K
19
0448
LightLas Pattern Scanning System - TruScan Pro
K
19
0083
Leaf Photocoagulator
K
18
1682
VISULAS green
K
18
0402
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
K
17
1488
PSLT for PASCAL Streamline
K
17
0067
Easyret
K
17
0302
YELLOW LASER PHOTOCOAGULATOR YLC-500
K
15
3769
R:GEN Laser System
K
15
2688
LightLas Multi-Wavelength Medical Laser System
K
15
2603
Green Laser Photocoagulator GYC-500
K
14
2398
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
K
14
2830
Ophthalmed Bending Laser Probes
K
14
2172
LIGHTMED TRUSCAN 577
K
13
3019
FIBERION OPHTHALMIC ENDOLASER PROBE
K
14
0362
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
K
13
3358
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
K
14
0336
OPTIMUS FUSION: SLT, YAG AND YAG/SLT
K
13
0195
SCANNING LASERLINK
K
13
1207
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
K
12
4043
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K
13
0933
SOLUTIS
K
12
2202
ELLEX 2RT
K
12
3542
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
K
12
3056
PASCAL LASER INDIRECT OPHTHALMOSCOPE
K
12
1187
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
K
12
0825
SUPRA SCAN DELIVERY SYSTEM
K
11
1460
OPTO HYALUS GREEN LASER
K
11
2154
FEMTO LDV
K
11
1643
OPTO MITRA YELLOW LASER
K
10
3547
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K
11
1108
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
K
10
3056
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
K
10
0253
VISUMAX LASER KERATOME
K
10
0019
PASCAL STREAMLINE PHOTOCOAGULATOR
K
09
1064
NAVILAS LASER SYSTEM
K
09
1981
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
K
09
2621
PASCAL STREAMLINE PHOTOCOAGULATOR
K
09
1534
LIGHTLAS MODEL 532
K
09
0774
LIGHTLAS SELECTOR
K
09
1581
SUPRA 577.Y LASER
K
08
1946
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
K
08
1774
SOLX 790 TITANIUM SAPPHIRE LASER
K
08
1565
INTEGRE PRO, MODEL L2RY
K
08
0423
INTEGRE, MODEL LP581
K
07
2823
MERILAS 532A
K
06
2624
NEXT GENERATION LASER
K
06
3297
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
K
07
0776
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
K
06
2074
IRIDEX WIRELESS FOOTSWITCH
K
06
1024
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
K
05
1944
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
K
05
0807
20G SMA LASER FIBER, MODEL LF100
K
05
0541
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
K
04
3613
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
K
04
3236
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
K
04
1598
LASEREX, MODEL LP4532
K
04
0209
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
K
03
3941
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K
03
1665
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
K
03
1023
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
K
02
3094
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K
02
1538
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
P
99
0078
HYPERION LTK SYSTEM
K
02
0374
OCULIGHT SL/SLX
K
01
3760
DC-3300 LASER DIODE PHOTOCOAGULATOR
K
01
0372
LIGHTLAS 532 PHOTOCOAGULATOR
P
99
0078
SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)
P
99
0078
HYPERION LTK SYSTEM
K
00
1772
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
K
99
0665
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
K
99
0075
LPULSA SYL-9000 OPHTHALMIC YAG LASER
K
98
1196
MEDITEC LINK
K
97
3193
LUXSCOPE
K
97
3220
RODENSTOCK LASER SLITLAMP
K
97
2514
LASEREX LP1532 PHOTOCOAGULATOR
K
97
1950
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
K
96
4751
CERALAS DIODE LASER SYSTEM (CERALAS D2)
K
96
0971
OCULIGHT GL
K
96
0522
DIOPEXY PROBE
K
95
1079
NIDEK MODEL GYC-1500 AND GYC-2000
K
95
2894
VISULINK 900 ARGON
K
94
2180
KEELER MULTILASE 3000
K
93
5747
MEGABEAM ENDOCULAR PROBE
K
93
1784
HGM ILLUMINATING IMAGING ENDOCULAR PROBE
K
93
2836
NIDEK MODEL AC-2300
K
93
2296
JR -- OPHTHALMIC ARGON LASER
K
92
5663
HGM ASPIRATING ENDOOCULAR(TM) PROBE
K
92
6470
LASER AND EMPHASIS SCLEROSTOMY TIP
K
91
0532
URAM OPHTHALMIC LASER ENDOSCOPE
K
91
0805
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K
90
4699
COMPAC(TM) DIODE LASERS
K
90
5453
CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND
K
91
0612
CANDELA DIODE TRABECULOPLASTY LASER DTL
K
90
5141
CENTAURI
K
90
3421
TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
K
90
4366
CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
K
90
0199
LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY
K
89
5213
MICROLASE BY LASER TRABECULOPLASTY
K
89
5196
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
K
89
4835
LASERMED* GOGGLES AND SPECTACLES
K
89
4273
NIDEK MODEL AKC-8000
K
89
3630
CANDELA UPC LASER PHOTOCOAGULATOR
K
89
3709
COHERENT MARIE ARGON PHOTOCOAGULATOR
K
89
0509
INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
K
89
0086
MICROLASE 8 0 0 (OPHTHALMIC LASER)
K
88
5164
LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM
K
88
2908
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
K
88
3213
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
K
88
1494
FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER
K
88
2372
RESUBMITTED DIODE LASER COAGULATOR
K
88
1134
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K
87
5000
PRISMA DISPOSABLE ENDO-OCULAR PROBE
K
87
4609
ZEISS VISULAS ARGON LASER
K
87
3460
OPHTHALAS DYE OPHTHALMIC LASER
K
87
2846
NIDEK ADC-8000 LASER SYSTEM
K
87
0839
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K
86
4063
ORION 3001, LASER PHOTOCOAGULATOR
K
86
3246
MIRALITE
K
86
3591
ENDOPHOTOCOAGULATION PROBE
K
86
2568
LDS - LASER DELIVERY SYSTEM
K
86
2987
MODEL 1000 OPHTHALMIC LASER SYSTEM
K
86
0358
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)
K
85
4949
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K
85
4288
OPHALMIC LASER PHOTOCOAGULATOR
K
85
3890
OPHTHALMIC LASER PHOTOCOAGULATOR
K
85
2529
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
K
85
2234
MDS 83 OPHTHALMIC DYE LASER SYSTEM
K
85
2464
HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
K
84
4357
SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR
K
85
0572
HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K
K
84
4668
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
K
84
4358
SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
K
84
3965
ARGON LASER PHOTOCOAGULATOR SYS
K
84
2251
AMERI. MEDICAL OPTICS ARGON LASER PHOTO
K
84
2250
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE
K
84
2412
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K
84
1855
AMER. MED. OPTICS ARGON LASER PHOTO
K
84
1856
AMER. MED. OPTICS ARGON/KRYPTON LASER
K
84
0590
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
K
84
0145
MONITOR CO2 LASER SURGICAL SYSTEM
K
83
4610
LASER LENS-VARIOUS MODELS
K
84
0854
MEDICAL LASER ENDOCOAGULATOR 5K
K
83
4305
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K
83
4060
RELIANCE OPHTHALMIC SLIT LAMP R-083
K
83
3532
OCULASE 514 OPHTHALMIC ARGON LASER
K
83
3533
LASER PHOTOCOAGULATOR 1520-A & K
K
83
2316
OPHTHALMIC ARGON LASER #700A
K
83
2089
MODEL 150K LASER COAGULATOR
K
83
3232
LASER PROTECTIVE EYESHIELD
K
83
3274
DERMATOLOGY HANDPIECE-OPHTH LASER
K
81
3492
BRITT KRYPTON LASERS 150K & 152K
K
81
2219
MODEL 900S INTRAOCULAR PROBE
K
80
1336
MODEL 900K PHOTOCOAGULATOR
K
79
1659
MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL
K
78
2106
COAGULATOR, MODEL 40 AARGON
K
78
1965
LASER COAGULATOR, MODEL 41AK
K
78
2065
LASER, PHOTOCOAGULATION
HQO
Unit, Cautery, Thermal, Ac-Powered
HQP
Unit, Cautery, Thermal, Battery-Powered
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
HQS
Burr, Corneal, Ac-Powered
HRF
Engine, Trephine, Accessories, Battery-Powered
HRG
Engine, Trephine, Accessories, Ac-Powered
HRH
Trephine, Manual, Ophthalmic
HRJ
Table, Instrument, Powered, Ophthalmic
HRK
Table, Instrument, Manual, Ophthalmic
HRN
Unit, Cryophthalmic, Ac-Powered
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
HRP
Pen, Marking, Surgical
KYB
Lens, Guide, Intraocular
KYG
Device, Irrigation, Ocular Surgery
LCC
Applicator, Ocular Pressure
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
LWL
Fluid, Intraocular
LXP
Plug, Scleral
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
LZP
Aid, Surgical, Viscoelastic
MLZ
Vitrectomy, Instrument Cutter
MMC
Dilator, Expansive Iris (Accessory)
MOE
Collagen Corneal Shield
MSR
Tubing, Replacement, Phacofragmentation Unit
MSS
Folders And Injectors, Intraocular Lens (Iol)
MUS
Fluidic, Phacoemulsification/Phacofragmentation
MXO
Laser, System, Phacolysis
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
MYD
Keratome, Water Jet
NCE
Injector, Capsular Tension Ring
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
NGY
Cannula, Trocar, Ophthalmic
NKX
Needle, Phacoemulsification, Reprocessed
NKY
Blade, Keratome, Reprocessed
NLA
Knife, Ophthalmic, Reprocessed
NVB
Intraocular, Pressure Measuring Device
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
OJK
Eye Tray
OOE
Ophthalmic Femtosecond Laser
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
PZG
Surgical Eye Tray
QDV
Iol Tray
QDW
Phaco Kit
QDY
Vitrectomy Kit
QGJ
Corneal Inlay Inserter Handle
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
PYU
Sponge, Eyelid Cleaning, Powered
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
surgical-devices
/
HQF
/
K910805
View Source
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910805
510(k) Type
Traditional
Applicant
HERAEUS LASERSONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/1991
Days to Decision
87 days