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
Mar 27, 2012
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
MSS
Folders And Injectors, Intraocular Lens (iol)
173d
Cleared
Mar 16, 2012
FEMTO LDV
HQF
Laser, Ophthalmic
233d
Cleared
Feb 16, 2012
KOWA VX-20
HKI
Camera, Ophthalmic, Ac-powered
188d
Cleared
Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
207d
Cleared
Jan 19, 2012
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
OBO
Tomography, Optical Coherence
269d
Cleared
Dec 21, 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
HQC
Unit, Phacofragmentation
211d
Cleared
Dec 21, 2011
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
132d
Cleared
Dec 21, 2011
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
28d
Cleared
Dec 19, 2011
LIPIFLOW THERMAL PULSATION SYSTEM
ORZ
Eyelid Thermal Pulsation System
94d
Cleared
Dec 08, 2011
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
HRN
Unit, Cryophthalmic, Ac-powered
139d
Cleared
Dec 05, 2011
EYE CARE CURE CONTACT LENS CASE
LRX
Case, Contact Lens
67d
Cleared
Dec 02, 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Dec 02, 2011
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Nov 30, 2011
NON-CONTACT TEAR FILM THERMOGRAGH
HKI
Camera, Ophthalmic, Ac-powered
160d
Cleared
Nov 22, 2011
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
OOE
Ophthalmic Femtosecond Laser
281d
Cleared
Nov 21, 2011
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
HQC
Unit, Phacofragmentation
90d
Cleared
Nov 08, 2011
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
188d
Cleared
Nov 08, 2011
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
OBO
Tomography, Optical Coherence
15d
Cleared
Nov 07, 2011
LAMINAR FLOW PHACO TIPS
HQC
Unit, Phacofragmentation
129d
Cleared
Nov 03, 2011
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
HQF
Laser, Ophthalmic
336d
Cleared
Nov 03, 2011
OPTO MITRA YELLOW LASER
HQF
Laser, Ophthalmic
143d
Cleared
Nov 02, 2011
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
HPZ
Implant, Eye Sphere
247d
Cleared
Nov 02, 2011
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
173d
Cleared
Nov 01, 2011
EYE-CEPT STERILE SALINE SOLUTION
LPN
Accessories, Soft Lens Products
280d
Cleared
Oct 28, 2011
EASYSCAN MODEL 1.2
MYC
Ophthalmoscope, Laser, Scanning
107d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices