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
2889 Ophthalmic devices
Cleared
Jun 06, 2000
C.S.O. TONOMETER
HKY
Tonometer, Manual
288d
Cleared
Jun 02, 2000
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
135d
Cleared
May 22, 2000
SPORTSIGHT GP
HQD
Lens, Contact (other Material) - Daily
213d
Cleared
May 19, 2000
MENICON SF-P
HQD
Lens, Contact (other Material) - Daily
113d
Cleared
May 19, 2000
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
NCF
Aberrometer, Ophthalmic
84d
Cleared
May 19, 2000
POLYMACON
LPL
Lenses, Soft Contact, Daily Wear
45d
Cleared
May 19, 2000
METHAFILCON A
LPL
Lenses, Soft Contact, Daily Wear
45d
Cleared
May 15, 2000
SOLO-CARE BRAND HARD SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
82d
Cleared
May 11, 2000
HEADLAMP HL2000.
FSR
Light, Headband, Surgical
136d
Cleared
Apr 20, 2000
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
LPN
Accessories, Soft Lens Products
84d
Cleared
Apr 19, 2000
BIOCERAMIC ORBITAL IMPLANT
HPZ
Implant, Eye Sphere
287d
Cleared
Apr 17, 2000
SUTUREGROOVE
MML
Weights, Eyelid, External
118d
Cleared
Apr 14, 2000
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
182d
Cleared
Apr 11, 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
MRC
Products, Contact Lens Care, Rigid Gas Permeable
84d
Cleared
Mar 20, 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
HKY
Tonometer, Manual
297d
Cleared
Mar 20, 2000
BLADEWORKS MICROKERATOME BLADE
HNO
Keratome, Ac-powered
175d
Cleared
Mar 20, 2000
IOLMASTER
HJO
Biomicroscope, Slit-lamp, Ac-powered
166d
Cleared
Mar 20, 2000
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
88d
Cleared
Mar 16, 2000
MSP M/K BLADE
HNO
Keratome, Ac-powered
178d
Cleared
Mar 15, 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
HNO
Keratome, Ac-powered
110d
Cleared
Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Mar 03, 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
87d
Cleared
Mar 02, 2000
HYLASHIELD CL
MRC
Products, Contact Lens Care, Rigid Gas Permeable
83d
Cleared
Feb 23, 2000
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Feb 23, 2000
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
63d
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