FDA 510(k) Ophthalmic Devices
FDA 510(k) Ophthalmic Devices - Regulatory Overview
FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.
Main categories:
- Contact lenses - daily, extended wear, toric and multifocal lenses
- Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
- Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
- Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
- Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2885 Ophthalmic devices
Cleared
May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
FSR
Light, Headband, Surgical
76d
Cleared
May 10, 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
222d
Cleared
Apr 28, 2011
ONE DAY FLAT PACK
LPL
Lenses, Soft Contact, Daily Wear
210d
Cleared
Apr 20, 2011
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Apr 08, 2011
ULTIMATE VIT ENHAMCER (UVE)
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
245d
Cleared
Feb 23, 2011
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
HQB
Photocoagulator And Accessories
28d
Cleared
Feb 09, 2011
AAIO-7, AAIO WIRLESS
HLI
Ophthalmoscope, Ac-powered
15d
Cleared
Feb 03, 2011
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
59d
Cleared
Feb 01, 2011
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
HQF
Laser, Ophthalmic
109d
Cleared
Jan 26, 2011
KOWA NONMYD WX
HKI
Camera, Ophthalmic, Ac-powered
230d
Cleared
Dec 10, 2010
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
HKX
Tonometer, Ac-powered
415d
Cleared
Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
HLJ
Ophthalmoscope, Battery-powered
374d
Cleared
Nov 03, 2010
IOLMASTER 500
HJO
Biomicroscope, Slit-lamp, Ac-powered
190d
Cleared
Sep 15, 2010
RTVUE MODEL RTVUE 100
HLI
Ophthalmoscope, Ac-powered
106d
Cleared
Aug 17, 2010
STELLARIS PC VISION ENHANCEMENT SYSTEM
HQC
Unit, Phacofragmentation
97d
Cleared
Jul 08, 2010
VISUMAX LASER KERATOME
HQF
Laser, Ophthalmic
161d
Cleared
Jun 17, 2010
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
HLI
Ophthalmoscope, Ac-powered
83d
Cleared
Apr 22, 2010
IVUE, MODEL 100
OBO
Tomography, Optical Coherence
345d
Cleared
Apr 02, 2010
ENHANCED ULTRA VIT PROBE
MLZ
Vitrectomy, Instrument Cutter
162d
Cleared
Mar 12, 2010
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
HPT
Perimeter, Automatic, Ac-powered
150d
Cleared
Mar 09, 2010
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
MRC
Products, Contact Lens Care, Rigid Gas Permeable
526d
Cleared
Mar 09, 2010
PSL CLASSIC SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
15d
Cleared
Jan 05, 2010
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
244d
Cleared
Nov 25, 2009
GDXPRO
MYC
Ophthalmoscope, Laser, Scanning
12d
Cleared
Nov 18, 2009
BPZ02 MULTIPURPOSE SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
336d
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