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
2884 Ophthalmic devices
Cleared
Dec 04, 2013
SELF-RETAINING BICANALICULUS INTUBATON SET II
OKS
Lacrimal Stents And Intubation Sets
293d
Cleared
Dec 04, 2013
HEINE BETA 200(R) OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
160d
Cleared
Nov 27, 2013
SPECULAR MICROSCOPE CEM-530
NQE
Microscope, Specular
268d
Cleared
Nov 14, 2013
PEREGRINE CURVED ILLUMINATING LASER PROBE
HQB
Photocoagulator And Accessories
85d
Cleared
Nov 01, 2013
SCANNING LASERLINK
HQF
Laser, Ophthalmic
277d
Cleared
Oct 30, 2013
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
HLJ
Ophthalmoscope, Battery-powered
140d
Cleared
Oct 30, 2013
SUNTOUCH EYE SPEAR
HOZ
Sponge, Ophthalmic
54d
Cleared
Oct 29, 2013
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
HOZ
Sponge, Ophthalmic
286d
Cleared
Oct 22, 2013
VISCOELASTIC INJECTOR
MRH
Pump, Infusion, Ophthalmic
74d
Cleared
Oct 18, 2013
LENSTEC LC INJECTION SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
395d
Cleared
Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
NFJ
System, Image Management, Ophthalmic
73d
Cleared
Oct 09, 2013
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
HQF
Laser, Ophthalmic
163d
Cleared
Oct 09, 2013
SYNERGY ODM
NFJ
System, Image Management, Ophthalmic
43d
Cleared
Sep 26, 2013
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
HQF
Laser, Ophthalmic
272d
Cleared
Sep 17, 2013
CRYSTALSERT DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
29d
Cleared
Sep 11, 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
LPL
Lenses, Soft Contact, Daily Wear
135d
Cleared
Sep 09, 2013
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
54d
Cleared
Aug 30, 2013
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
148d
Cleared
Aug 30, 2013
SUS (STENFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
108d
Cleared
Aug 30, 2013
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
50d
Cleared
Aug 06, 2013
MENICON NECT CONTACT LENS CASE
LRX
Case, Contact Lens
43d
Cleared
Aug 05, 2013
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
175d
Cleared
Aug 02, 2013
SOLUTIS
HQF
Laser, Ophthalmic
120d
Cleared
Jul 29, 2013
OPHTACATH KIT
OKS
Lacrimal Stents And Intubation Sets
229d
Cleared
Jul 26, 2013
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
MVN
Lens, Contact, (disposable)
165d
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