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
2885 Ophthalmic devices
Cleared
Oct 25, 2011
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
MVN
Lens, Contact, (disposable)
88d
Cleared
Oct 19, 2011
TBD
OOE
Ophthalmic Femtosecond Laser
89d
Cleared
Oct 17, 2011
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
HQB
Photocoagulator And Accessories
196d
Cleared
Sep 27, 2011
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
HQC
Unit, Phacofragmentation
102d
Cleared
Sep 20, 2011
FULL AUTO TONOMETER MODEL TX-20
HKX
Tonometer, Ac-powered
92d
Cleared
Sep 15, 2011
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
LPL
Lenses, Soft Contact, Daily Wear
66d
Cleared
Sep 15, 2011
SILICONE SPHERES
HPZ
Implant, Eye Sphere
49d
Cleared
Sep 14, 2011
DIGITAL RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
97d
Cleared
Sep 08, 2011
RTVUE CAM WITH CORNEAL POWER UPGRADE
OBO
Tomography, Optical Coherence
100d
Cleared
Aug 30, 2011
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
HJO
Biomicroscope, Slit-lamp, Ac-powered
224d
Cleared
Aug 19, 2011
P200T
MYC
Ophthalmoscope, Laser, Scanning
70d
Cleared
Aug 11, 2011
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
HQF
Laser, Ophthalmic
113d
Cleared
Jul 28, 2011
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
LPL
Lenses, Soft Contact, Daily Wear
181d
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 03, 2011
ISTAND
HLI
Ophthalmoscope, Ac-powered
211d
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
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices