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
2888 Ophthalmic devices
Cleared
Dec 15, 2003
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
MVN
Lens, Contact, (disposable)
20d
Cleared
Dec 04, 2003
NON-CONTACT TONOMETER, MODEL NT-4000
HKX
Tonometer, Ac-powered
183d
Cleared
Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
HLJ
Ophthalmoscope, Battery-powered
142d
Cleared
Nov 24, 2003
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
MPA
Endoilluminator
91d
Cleared
Nov 14, 2003
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
LPN
Accessories, Soft Lens Products
170d
Cleared
Nov 07, 2003
PROCLEAR COMPATIBLES MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Oct 20, 2003
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
HNO
Keratome, Ac-powered
26d
Cleared
Sep 12, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
205d
Cleared
Aug 26, 2003
DISPOSABLE N-PE MICKROKERATOME BLADES
HNO
Keratome, Ac-powered
32d
Cleared
Aug 21, 2003
CENTURION SES EPIKERATOME
HNO
Keratome, Ac-powered
78d
Cleared
Aug 14, 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
50d
Cleared
Aug 11, 2003
LED HEADLIGHT
FSR
Light, Headband, Surgical
87d
Cleared
Aug 11, 2003
SOLID STATE LAMP [LED] HEADLIGHT
FSR
Light, Headband, Surgical
87d
Cleared
Jun 27, 2003
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
HQF
Laser, Ophthalmic
88d
Cleared
Jun 27, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
43d
Cleared
Jun 27, 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
43d
Cleared
Jun 19, 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
HNO
Keratome, Ac-powered
133d
Cleared
Jun 06, 2003
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
HKI
Camera, Ophthalmic, Ac-powered
10d
Cleared
May 02, 2003
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
130d
Cleared
May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
HLI
Ophthalmoscope, Ac-powered
80d
Cleared
Feb 28, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
136d
Cleared
Feb 26, 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
Feb 26, 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
Feb 21, 2003
MACROPORE SURGICAL BARRIER FILM
MTZ
Wrap, Implant, Orbital
114d
Cleared
Feb 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
70d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices