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
2889 Ophthalmic devices
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
Apr 03, 2002
RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
141d
Cleared
Mar 04, 2002
STAURENGHI WIDE FIELD SCANNING LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
74d
Cleared
Feb 20, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
61d
Cleared
Feb 11, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
115d
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
Dec 19, 2001
MEDPOR COATED TEAR DRAIN
OKS
Lacrimal Stents And Intubation Sets
166d
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 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 02, 2001
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
NGY
Cannula, Trocar, Ophthalmic
63d
Cleared
Sep 12, 2001
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
HQD
Lens, Contact (other Material) - Daily
83d
Cleared
Aug 24, 2001
DISPOSABLE VITRECTOMY LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
50d
Cleared
Aug 24, 2001
ULTRACELL ABSORBENT STICK
HOZ
Sponge, Ophthalmic
42d
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
Jun 19, 2001
MEDPOR QUAD MOTILITY IMPLANT
HPZ
Implant, Eye Sphere
85d
Cleared
Apr 27, 2001
HANSATOME MICROKERATOME
HNO
Keratome, Ac-powered
88d
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