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 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
Cleared
Apr 27, 1999
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
75d
Cleared
Apr 21, 1999
PVS BASICS
HQD
Lens, Contact (other Material) - Daily
128d
Cleared
Apr 21, 1999
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA
LPL
Lenses, Soft Contact, Daily Wear
44d
Cleared
Apr 20, 1999
FLEXPLUG
LZU
Plug, Punctum
18d
Cleared
Apr 16, 1999
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
78d
Cleared
Apr 14, 1999
OXYCON LENS
HQD
Lens, Contact (other Material) - Daily
28d
Cleared
Apr 12, 1999
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
MML
Weights, Eyelid, External
77d
Cleared
Apr 04, 1999
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
HQR
Apparatus, Cautery, Radiofrequency, Ac-powered
86d
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