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
Jul 27, 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
HQB
Photocoagulator And Accessories
57d
Cleared
Jul 14, 2011
CARA
NFJ
System, Image Management, Ophthalmic
107d
Cleared
Jul 14, 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
LRX
Case, Contact Lens
15d
Cleared
Jul 08, 2011
RHA2020
HLI
Ophthalmoscope, Ac-powered
36d
Cleared
Jun 29, 2011
ASICO SOFTIP INJECTOR SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
212d
Cleared
Jun 29, 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
167d
Not Cleared
Jun 28, 2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
ORZ
Eyelid Thermal Pulsation System
323d
Cleared
Jun 23, 2011
VISTA DIGITAL OPTHALMOSCOPE
HKI
Camera, Ophthalmic, Ac-powered
303d
Cleared
Jun 03, 2011
ISTAND
HLI
Ophthalmoscope, Ac-powered
211d
Cleared
Jun 01, 2011
UNIT, PHACOFRAGMENTATION
HQC
Unit, Phacofragmentation
232d
Cleared
May 23, 2011
SLIT LAMP SL-2G
HJO
Biomicroscope, Slit-lamp, Ac-powered
90d
Cleared
May 20, 2011
CLEARCUT S SAFETY KNIFE
HNN
Knife, Ophthalmic
120d
Cleared
May 18, 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
NFJ
System, Image Management, Ophthalmic
135d
Cleared
May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
HKI
Camera, Ophthalmic, Ac-powered
38d
Cleared
May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
FSR
Light, Headband, Surgical
76d
Cleared
May 10, 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
222d
Cleared
Apr 28, 2011
ONE DAY FLAT PACK
LPL
Lenses, Soft Contact, Daily Wear
210d
Cleared
Apr 26, 2011
NOVAKONE SPHERICAL AND TORIC LENSES
LPL
Lenses, Soft Contact, Daily Wear
231d
Cleared
Apr 20, 2011
RETCAM 3 OPTHALMIC IMAGING SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
202d
Cleared
Apr 20, 2011
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Apr 08, 2011
ULTIMATE VIT ENHAMCER (UVE)
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
245d
Cleared
Mar 16, 2011
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
OOE
Ophthalmic Femtosecond Laser
175d
Cleared
Feb 25, 2011
ADAPT, MODEL AX-03SN
OUM
Adaptometer (biophotometer), Software-based Data Acquisition And Stimulus Generation
324d
Cleared
Feb 23, 2011
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
HQB
Photocoagulator And Accessories
28d
Cleared
Feb 09, 2011
AAIO-7, AAIO WIRLESS
HLI
Ophthalmoscope, Ac-powered
15d
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