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
Jul 31, 2012
VICTUS LASER PLATFORM
OOE
Ophthalmic Femtosecond Laser
169d
Cleared
Jul 20, 2012
CAUTERY
HQP
Unit, Cautery, Thermal, Battery-powered
66d
Cleared
Jul 11, 2012
AC LENS BRANDED CONTACT LENS CASE
LRX
Case, Contact Lens
103d
Cleared
Jul 06, 2012
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
LRX
Case, Contact Lens
92d
Cleared
Jun 28, 2012
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
HQD
Lens, Contact (other Material) - Daily
87d
Cleared
Jun 21, 2012
VERSAVIT
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
15d
Cleared
Jun 18, 2012
CIRRUS PHOTO
OBO
Tomography, Optical Coherence
326d
Cleared
Jun 15, 2012
INFINITI(R) VISION SYSTEM
HQC
Unit, Phacofragmentation
81d
Cleared
Jun 08, 2012
TBD
OOE
Ophthalmic Femtosecond Laser
136d
Cleared
Jun 05, 2012
BAUSCH + LOMB NESOFILCON A CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
172d
Cleared
May 31, 2012
NCI SPATULA
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
442d
Cleared
May 30, 2012
PROCARE PLUS VITRECTOMY SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
132d
Cleared
May 25, 2012
OPTOS ADVANCE
NFJ
System, Image Management, Ophthalmic
161d
Cleared
May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
HLI
Ophthalmoscope, Ac-powered
123d
Cleared
May 10, 2012
ILWAIT TIMER OCULOPRESSOR
LCC
Applicator, Ocular Pressure
218d
Cleared
May 08, 2012
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
HKI
Camera, Ophthalmic, Ac-powered
169d
Cleared
Apr 30, 2012
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
LPN
Accessories, Soft Lens Products
210d
Cleared
Apr 26, 2012
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
398d
Cleared
Apr 23, 2012
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
HQB
Photocoagulator And Accessories
115d
Cleared
Apr 18, 2012
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
135d
Cleared
Apr 17, 2012
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
104d
Cleared
Apr 11, 2012
KONAN SPECULAR MICROSCOPE XIV
NQE
Microscope, Specular
72d
Cleared
Apr 03, 2012
AVAIRA (ENFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
104d
Cleared
Apr 03, 2012
RTVUE XR OCT
HLI
Ophthalmoscope, Ac-powered
68d
Cleared
Mar 30, 2012
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
LPL
Lenses, Soft Contact, Daily Wear
155d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices