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
Jun 06, 2003
ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP
LPL
Lenses, Soft Contact, Daily Wear
81d
Cleared
Jun 06, 2003
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
HKI
Camera, Ophthalmic, Ac-powered
10d
Cleared
May 30, 2003
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC
LPL
Lenses, Soft Contact, Daily Wear
94d
Cleared
May 22, 2003
DIGNITY OPHTHALMIC SURGICAL SYSTEM
HQC
Unit, Phacofragmentation
17d
Cleared
May 14, 2003
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
65d
Cleared
May 09, 2003
OPAQUE HERRICK LACRIMAL PLUG
LZU
Plug, Punctum
100d
Cleared
May 06, 2003
RTA MODEL D RETINAL THICKNESS ANALYZER
HLI
Ophthalmoscope, Ac-powered
12d
Cleared
May 02, 2003
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
130d
Cleared
May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
HLI
Ophthalmoscope, Ac-powered
80d
Cleared
Apr 25, 2003
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
OKS
Lacrimal Stents And Intubation Sets
81d
Cleared
Apr 24, 2003
APPLANATION TONOMETER
HKX
Tonometer, Ac-powered
174d
Cleared
Apr 17, 2003
VELOCITY ADVANTAGE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
142d
Cleared
Apr 17, 2003
OPHTEC ENCLAVATION NEEDLE
HNQ
Hook, Ophthalmic
64d
Cleared
Apr 04, 2003
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
84d
Cleared
Apr 04, 2003
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
43d
Cleared
Apr 02, 2003
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
76d
Cleared
Apr 01, 2003
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT
LPL
Lenses, Soft Contact, Daily Wear
88d
Cleared
Mar 13, 2003
EXPRESS MINI GLAUCOMA SHUNT
KYF
Implant, Eye Valve
38d
Cleared
Feb 28, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
136d
Cleared
Feb 26, 2003
SCLERAL PLUGS, 19 AND 20 GAUGE
LXP
Plug, Scleral
236d
Cleared
Feb 26, 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
Feb 26, 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
Feb 26, 2003
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
51d
Cleared
Feb 21, 2003
MACROPORE SURGICAL BARRIER FILM
MTZ
Wrap, Implant, Orbital
114d
Cleared
Feb 20, 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
HKY
Tonometer, Manual
94d
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