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
Jul 16, 1999
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
85d
Cleared
Jul 13, 1999
SCLERAL PLUGS, 19 AND 20 GAUGE
LXP
Plug, Scleral
119d
Cleared
Jul 13, 1999
AHMED GLAUCOMA VALVE IMPLANT
KYF
Implant, Eye Valve
104d
Cleared
Jul 08, 1999
FCI CRAWFORD PROBE INTUBATION SETS
OKS
Lacrimal Stents And Intubation Sets
87d
Cleared
Jul 07, 1999
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
233d
Cleared
Jul 07, 1999
OCUSYSTEM ART ADVANTAGE, MODEL 995
HQC
Unit, Phacofragmentation
36d
Cleared
Jul 07, 1999
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
20d
Cleared
Jun 29, 1999
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C
HQD
Lens, Contact (other Material) - Daily
35d
Cleared
Jun 29, 1999
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
35d
Cleared
Jun 29, 1999
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)
LPL
Lenses, Soft Contact, Daily Wear
14d
Cleared
Jun 28, 1999
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
96d
Cleared
Jun 08, 1999
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
62d
Cleared
Jun 07, 1999
LEICA AT550
HKX
Tonometer, Ac-powered
83d
Cleared
Jun 03, 1999
THERMAL CAUTERY DEVICE, FORCEPS
HQP
Unit, Cautery, Thermal, Battery-powered
90d
Cleared
Jun 03, 1999
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
84d
Cleared
May 18, 1999
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
OKS
Lacrimal Stents And Intubation Sets
77d
Cleared
May 17, 1999
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
HQF
Laser, Ophthalmic
76d
Cleared
May 14, 1999
KERATOME SYSTEM, MODEL K3000
HMY
Keratome, Battery-powered
144d
Cleared
May 14, 1999
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
10d
Cleared
May 11, 1999
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
127d
Cleared
May 10, 1999
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
174d
Cleared
May 10, 1999
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
LPN
Accessories, Soft Lens Products
83d
Cleared
May 10, 1999
DRAINAGE WICK
HOZ
Sponge, Ophthalmic
69d
Cleared
May 06, 1999
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
34d
Cleared
Apr 28, 1999
KERAVISION VACUUM RING SYSTEM
HNO
Keratome, Ac-powered
128d
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