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
5119
Total
5101
Cleared
169d
Avg (2y)
1976
Since
5119 Ophthalmic devices
Cleared
Nov 01, 2002
STEPHENS DISPOSABLE SCISSORS
HNF
Scissors, Ophthalmic
66d
Cleared
Nov 01, 2002
STEPHENS DISPOSABLE HOOKS
HNQ
Hook, Ophthalmic
66d
Cleared
Nov 01, 2002
GAYHEART CORNEAL EXCISION DEVICE
HRH
Trephine, Manual, Ophthalmic
66d
Cleared
Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
164d
Cleared
Oct 21, 2002
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
NJJ
Tonometer, Analyzer, Ocular Blood Flow
21d
Cleared
Oct 18, 2002
SMART PLUG, MODEL 500
LZU
Plug, Punctum
116d
Cleared
Oct 18, 2002
BD K-4000 MICROKERATOME SYSTEM
HMY
Keratome, Battery-powered
30d
Cleared
Oct 18, 2002
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
NCF
Aberrometer, Ophthalmic
18d
Cleared
Oct 16, 2002
MOIST PUNCTAL PLUG SYSTEM
LZU
Plug, Punctum
126d
Cleared
Oct 16, 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
HMY
Keratome, Battery-powered
69d
Cleared
Oct 11, 2002
KOWA AUTOMATED TONOMETER KT-500
HKX
Tonometer, Ac-powered
330d
Cleared
Oct 11, 2002
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL
HQD
Lens, Contact (other Material) - Daily
136d
Cleared
Oct 11, 2002
TGDC-01 PRA
HKX
Tonometer, Ac-powered
121d
Cleared
Oct 11, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
HNO
Keratome, Ac-powered
57d
Cleared
Oct 11, 2002
CONTACT LASER & DIAGNOSTIC LENSES
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
14d
Cleared
Oct 07, 2002
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
NJH
Lens, Spectacle (prescription), For Reading Discomfort
77d
Cleared
Oct 03, 2002
DISPOSABLE N-PE MICROKERATOME BLADES
HNO
Keratome, Ac-powered
90d
Cleared
Sep 27, 2002
M2 SINGLE USE MICROKERTOME
HMY
Keratome, Battery-powered
56d
Cleared
Sep 26, 2002
MICRORUPTER V
LXS
Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
14d
Cleared
Sep 24, 2002
ICASE
LRX
Case, Contact Lens
158d
Cleared
Sep 24, 2002
LUNEAU 3 MIRROR LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
62d
Cleared
Sep 12, 2002
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
87d
Cleared
Sep 09, 2002
BENJAMIN ENVOY PHACO HANDPIECE
HQC
Unit, Phacofragmentation
14d
Cleared
Sep 04, 2002
IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
Aug 29, 2002
ALPHACOR
HQM
Keratoprosthesis, Permanent Implant
289d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices