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
Dec 26, 2001
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
133d
Cleared
Dec 26, 2001
OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
70d
Cleared
Dec 26, 2001
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
Dec 20, 2001
SAUFLON MULTI LENS CARE SYSTEM
LPN
Accessories, Soft Lens Products
297d
Cleared
Dec 20, 2001
BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
69d
Cleared
Dec 20, 2001
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
59d
Cleared
Dec 19, 2001
MEDPOR COATED TEAR DRAIN
OKS
Lacrimal Stents And Intubation Sets
166d
Cleared
Dec 19, 2001
ANISEIKONIA INSPECTOR
HJT
Haploscope
161d
Cleared
Dec 14, 2001
ASMOTOM AUTOMATED TREPHINE SYSTEM
HRG
Engine, Trephine, Accessories, Ac-powered
85d
Cleared
Dec 13, 2001
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
HNO
Keratome, Ac-powered
65d
Cleared
Dec 06, 2001
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
171d
Cleared
Nov 20, 2001
SEREINE EXTRA STRENGTH DAILY CLEANER
LPN
Accessories, Soft Lens Products
183d
Cleared
Nov 20, 2001
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
LPL
Lenses, Soft Contact, Daily Wear
55d
Cleared
Nov 20, 2001
CYBERCASES BY BAUSCH & LOMB
LRX
Case, Contact Lens
54d
Cleared
Nov 20, 2001
TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
33d
Cleared
Nov 20, 2001
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
33d
Cleared
Nov 19, 2001
DOCUMENTING LASER SLIT LAMP, DP 2010
HJO
Biomicroscope, Slit-lamp, Ac-powered
84d
Cleared
Nov 09, 2001
VANGUARD REPROCESSED PHACOEMULSIFICATION
NKX
Needle, Phacoemulsification, Reprocessed
87d
Cleared
Nov 08, 2001
REPROCESSED PHACO TIPS
NKX
Needle, Phacoemulsification, Reprocessed
91d
Cleared
Nov 06, 2001
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
HNO
Keratome, Ac-powered
201d
Cleared
Nov 01, 2001
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
146d
Cleared
Oct 26, 2001
CONFOSCAN 2 CONFOCAL MICROSCOPE
HJO
Biomicroscope, Slit-lamp, Ac-powered
88d
Cleared
Oct 22, 2001
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
MSS
Folders And Injectors, Intraocular Lens (iol)
168d
Cleared
Oct 22, 2001
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
HRN
Unit, Cryophthalmic, Ac-powered
60d
Cleared
Oct 12, 2001
BIOMEDICS UV MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
74d
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