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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
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
K
20
0874
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
2
Cleared 510(K)
K
14
1330
ENDO-CORD
2
Cleared 510(K)
K
12
2637
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
2
Cleared 510(K)
K
11
3697
EIGR SURGICAL ILLUMINATION SYSTEM
2
Cleared 510(K)
K
11
3330
CABLECAP
2
Cleared 510(K)
K
10
2266
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
2
Cleared 510(K)
K
10
1496
CABLECAP MODEL: WLF, STZ, ACM
2
Cleared 510(K)
K
10
0388
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
2
Cleared 510(K)
K
10
0395
HARMONY VLED SURGICAL LIGHTNING SYSTEM
2
Cleared 510(K)
K
09
3386
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
2
Cleared 510(K)
K
09
0070
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
2
Cleared 510(K)
K
08
3710
RETRACTOR LITE
2
Cleared 510(K)
K
08
2992
AXXION LIGHT GUIDE
2
Cleared 510(K)
K
08
0962
LITE WAND II
2
Cleared 510(K)
K
08
0367
ZIMMER MIS LIGHT
2
Cleared 510(K)
K
07
1218
PROXENON 350, MODEL 902XX
2
Cleared 510(K)
K
06
1690
SURGICAL HEADLIGHT
2
Cleared 510(K)
K
05
3227
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
2
Cleared 510(K)
K
05
1786
MELIDE FIBEROPTIC LIGHT
2
Cleared 510(K)
K
04
2034
NUVASIVE MAXCESS LIGHT GUIDE
2
Cleared 510(K)
K
00
3577
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
2
Cleared 510(K)
K
00
0728
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
2
Cleared 510(K)
K
99
1572
ISOLUX SURGICAL HEADLIGHT
2
Cleared 510(K)
K
97
2225
UFR FIBEROPTIC CABLE
2
Cleared 510(K)
K
95
5510
X6000D SILENT SUN LIGHT SOURCE
2
Cleared 510(K)
K
93
6048
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
2
Cleared 510(K)
K
93
1546
END-IRRIGATING ENDOILLUMINATOR
2
Cleared 510(K)
K
92
2820
WOODBINE XT350, XENON ARC LIGHT SOURCE
2
Cleared 510(K)
K
92
2544
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
2
Cleared 510(K)
K
92
1646
NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
2
Cleared 510(K)
K
91
5274
METAL HALIDE LIGHT SOURCE MODEL LM 250
2
Cleared 510(K)
K
91
2252
INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
2
Cleared 510(K)
K
90
3800
FIBER OPTIC LIGHT CABLE
2
Cleared 510(K)
K
90
1491
CUDA SURGICAL LIGHT
2
Cleared 510(K)
K
90
1035
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
2
Cleared 510(K)
K
89
3828
ML-800 AUTOELECTRONIC LIGHT SOURCE
2
Cleared 510(K)
K
89
3491
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
2
Cleared 510(K)
K
87
5006
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
2
Cleared 510(K)
K
87
5007
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
2
Cleared 510(K)
K
87
5005
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
2
Cleared 510(K)
K
87
5004
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
2
Cleared 510(K)
K
87
5195
OPHTHALMIC LIGHT PIPE PICK
2
Cleared 510(K)
K
87
0942
MVS FIBEROPTIC LIGHTPIPE
2
Cleared 510(K)
K
86
4380
LUTEX HEADLIGHT SYSTEMS
2
Cleared 510(K)
K
76
1142
HEADLIGHTS W/ FILTER-OPTICO CABLES
2
Cleared 510(K)
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
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 6 December 2024 at 11:05 pm
SU
/
subpart-e—surgical-devices
/
FST
/
K955510
View Source
X6000D SILENT SUN LIGHT SOURCE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K955510
510(k) Type
Traditional
Applicant
PRODUCTS FOR MEDICINE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/31/1996
Days to Decision
58 days
Submission Type
Statement
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
K
20
0874
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
K
14
1330
ENDO-CORD
K
12
2637
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
K
11
3697
EIGR SURGICAL ILLUMINATION SYSTEM
K
11
3330
CABLECAP
K
10
2266
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
K
10
1496
CABLECAP MODEL: WLF, STZ, ACM
K
10
0388
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
K
10
0395
HARMONY VLED SURGICAL LIGHTNING SYSTEM
K
09
3386
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
K
09
0070
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
K
08
3710
RETRACTOR LITE
K
08
2992
AXXION LIGHT GUIDE
K
08
0962
LITE WAND II
K
08
0367
ZIMMER MIS LIGHT
K
07
1218
PROXENON 350, MODEL 902XX
K
06
1690
SURGICAL HEADLIGHT
K
05
3227
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
K
05
1786
MELIDE FIBEROPTIC LIGHT
K
04
2034
NUVASIVE MAXCESS LIGHT GUIDE
K
00
3577
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K
00
0728
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
K
99
1572
ISOLUX SURGICAL HEADLIGHT
K
97
2225
UFR FIBEROPTIC CABLE
K
95
5510
X6000D SILENT SUN LIGHT SOURCE
K
93
6048
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
K
93
1546
END-IRRIGATING ENDOILLUMINATOR
K
92
2820
WOODBINE XT350, XENON ARC LIGHT SOURCE
K
92
2544
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K
92
1646
NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
K
91
5274
METAL HALIDE LIGHT SOURCE MODEL LM 250
K
91
2252
INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
K
90
3800
FIBER OPTIC LIGHT CABLE
K
90
1491
CUDA SURGICAL LIGHT
K
90
1035
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
K
89
3828
ML-800 AUTOELECTRONIC LIGHT SOURCE
K
89
3491
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K
87
5006
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
K
87
5007
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K
87
5005
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K
87
5004
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K
87
5195
OPHTHALMIC LIGHT PIPE PICK
K
87
0942
MVS FIBEROPTIC LIGHTPIPE
K
86
4380
LUTEX HEADLIGHT SYSTEMS
K
76
1142
HEADLIGHTS W/ FILTER-OPTICO CABLES
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
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
/
FST
/
K955510
View Source
X6000D SILENT SUN LIGHT SOURCE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K955510
510(k) Type
Traditional
Applicant
PRODUCTS FOR MEDICINE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/31/1996
Days to Decision
58 days
Submission Type
Statement