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
5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1303 Ophthalmic devices
Cleared
Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
98d
Cleared
Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
164d
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
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
HMY
Keratome, Battery-powered
69d
Cleared
Jul 02, 2002
INFINITI
HQC
Unit, Phacofragmentation
50d
Cleared
Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
HNO
Keratome, Ac-powered
30d
Cleared
Apr 26, 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
79d
Cleared
Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
HKI
Camera, Ophthalmic, Ac-powered
111d
Cleared
Apr 09, 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
LPL
Lenses, Soft Contact, Daily Wear
83d
Cleared
Apr 03, 2002
AQUIFY LENS COMFORT DROPS
MRC
Products, Contact Lens Care, Rigid Gas Permeable
190d
Cleared
Mar 04, 2002
STAURENGHI WIDE FIELD SCANNING LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
74d
Cleared
Feb 11, 2002
DC-3300 LASER DIODE PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
90d
Cleared
Dec 26, 2001
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
133d
Cleared
Dec 20, 2001
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
59d
Cleared
Nov 20, 2001
CYBERCASES BY BAUSCH & LOMB
LRX
Case, Contact Lens
54d
Cleared
Nov 19, 2001
DOCUMENTING LASER SLIT LAMP, DP 2010
HJO
Biomicroscope, Slit-lamp, Ac-powered
84d
Cleared
Nov 08, 2001
REPROCESSED PHACO TIPS
NKX
Needle, Phacoemulsification, Reprocessed
91d
Cleared
Nov 01, 2001
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
146d
Cleared
Oct 02, 2001
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
NGY
Cannula, Trocar, Ophthalmic
63d
Cleared
Aug 24, 2001
DISPOSABLE VITRECTOMY LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
50d
Cleared
Jul 25, 2001
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
MVN
Lens, Contact, (disposable)
51d
Cleared
Jul 02, 2001
PROVIEW EYE PRESSURE MONITOR
HKY
Tonometer, Manual
74d
Cleared
Jun 26, 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
HOZ
Sponge, Ophthalmic
68d
Cleared
Apr 27, 2001
HANSATOME MICROKERATOME
HNO
Keratome, Ac-powered
88d
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