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
Nov 13, 1986
KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
HJB
Instrument, Measuring, Corneal Radius
28d
Cleared
Nov 13, 1986
ORION 3001, LASER PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
24d
Cleared
Nov 13, 1986
FAULKNER FORCEPS
HNR
Forceps, Ophthalmic
24d
Cleared
Nov 13, 1986
OPTI-BRUSH
LPN
Accessories, Soft Lens Products
21d
Cleared
Nov 10, 1986
OPTEC 1000 DMV
HOX
Chart, Visual Acuity
62d
Cleared
Nov 10, 1986
CHARTER LABORATORIES INC. LENS LUBRICANT
HPX
Lens, Contact (polymethylmethacrylate)
27d
Cleared
Nov 10, 1986
EXETER OPERATING LOUPE
HJH
Loupe, Binocular, Low Power
27d
Cleared
Oct 31, 1986
MIRALITE
HQF
Laser, Ophthalmic
70d
Cleared
Oct 31, 1986
GRIESHABER GLOBAL CONTROL TUBING SET
HQC
Unit, Phacofragmentation
53d
Cleared
Oct 31, 1986
CATARACT DIAMOND KNIFE
HNN
Knife, Ophthalmic
38d
Cleared
Oct 31, 1986
FIXATION INSTRUMENTS
HNR
Forceps, Ophthalmic
38d
Cleared
Oct 31, 1986
THE ERGOSYSTEM CHAIR
HME
Chair, Ophthalmic, Ac-powered
38d
Cleared
Oct 31, 1986
THORTON TITANIUM HOOK ANGLED RIGHT
HNQ
Hook, Ophthalmic
17d
Cleared
Oct 31, 1986
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
HNC
Specula, Ophthalmic
17d
Cleared
Oct 31, 1986
THORNTON TITANIUM SILVER SPATULA
HND
Spatula, Ophthalmic
17d
Cleared
Oct 31, 1986
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND
HNR
Forceps, Ophthalmic
17d
Cleared
Oct 31, 1986
THORNTON TITANIUM FORCEPS (VARIOUS TYPES)
HNR
Forceps, Ophthalmic
17d
Cleared
Oct 31, 1986
VTS REPORTER OR VTS LINK
HPF
Aid, Vision, Electronic, Ac-powered
17d
Cleared
Oct 31, 1986
VIEWSCAN
HOT
Aid, Vision Image Intensification
17d
Cleared
Oct 31, 1986
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
HNR
Forceps, Ophthalmic
17d
Cleared
Oct 31, 1986
GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT
HQC
Unit, Phacofragmentation
16d
Cleared
Oct 24, 1986
SUNGLASSES (NON-PRESCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
225d
Cleared
Oct 20, 1986
MEDITRADE ARTIFICIAL EYES AND IMPLANTS
HPZ
Implant, Eye Sphere
74d
Cleared
Oct 20, 1986
OPHTHALMIC SURGICAL DRAPE
32d
Cleared
Oct 20, 1986
OPHTHALMIC SURGICAL OCULAR MARKERS
HMR
Marker, Ocular
32d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices