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
Feb 12, 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
HKI
Camera, Ophthalmic, Ac-powered
18d
Cleared
Jan 28, 2010
ATLANTIS SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
121d
Cleared
Jan 19, 2010
KEELER APPLANATION TONOMETER
HKY
Tonometer, Manual
90d
Cleared
Jan 05, 2010
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
244d
Cleared
Dec 23, 2009
FORESEE HOME
HPT
Perimeter, Automatic, Ac-powered
204d
Cleared
Dec 18, 2009
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
LPL
Lenses, Soft Contact, Daily Wear
268d
Cleared
Dec 18, 2009
LED LAMP OR OTHER
HJO
Biomicroscope, Slit-lamp, Ac-powered
91d
Cleared
Dec 11, 2009
LENSX 550 LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
106d
Cleared
Dec 04, 2009
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
MSS
Folders And Injectors, Intraocular Lens (iol)
197d
Cleared
Dec 03, 2009
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
HJO
Biomicroscope, Slit-lamp, Ac-powered
9d
Cleared
Nov 25, 2009
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
HKI
Camera, Ophthalmic, Ac-powered
289d
Cleared
Nov 25, 2009
GDXPRO
MYC
Ophthalmoscope, Laser, Scanning
12d
Cleared
Nov 18, 2009
BPZ02 MULTIPURPOSE SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
336d
Cleared
Nov 17, 2009
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
HKI
Camera, Ophthalmic, Ac-powered
104d
Cleared
Oct 27, 2009
NAVILAS LASER SYSTEM
HQF
Laser, Ophthalmic
196d
Cleared
Oct 27, 2009
FLUID ISOLATION DEVICE
HQC
Unit, Phacofragmentation
119d
Cleared
Oct 23, 2009
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
HOZ
Sponge, Ophthalmic
179d
Cleared
Oct 23, 2009
LIPIVIEW OCULAR SURFACE INTERFEROMETER
HKI
Camera, Ophthalmic, Ac-powered
115d
Cleared
Oct 20, 2009
LENSTAR, MODEL LS900
HJO
Biomicroscope, Slit-lamp, Ac-powered
385d
Cleared
Oct 20, 2009
ALCON ULTRACHOPPER
HQC
Unit, Phacofragmentation
125d
Cleared
Oct 01, 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
HKI
Camera, Ophthalmic, Ac-powered
86d
Cleared
Sep 28, 2009
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
HQF
Laser, Ophthalmic
89d
Cleared
Sep 25, 2009
PASCAL STREAMLINE PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
30d
Cleared
Sep 18, 2009
LIGHTLAS MODEL 532
HQF
Laser, Ophthalmic
115d
Cleared
Sep 03, 2009
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
300d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices