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 23, 1998
ML MICROKERATOME
HNO
Keratome, Ac-powered
121d
Cleared
Jul 22, 1998
REFRACTEC MCS-100
HQR
Apparatus, Cautery, Radiofrequency, Ac-powered
162d
Cleared
Jul 15, 1998
OCULOSTAT
HNC
Specula, Ophthalmic
103d
Cleared
Jul 09, 1998
TITANIUM PEG SYSTEM
MQU
Ocular Peg
128d
Cleared
Jul 09, 1998
SURGIN KIT
MSR
Tubing, Replacement, Phacofragmentation Unit
154d
Cleared
Jul 09, 1998
MONARCH IOL DELIVERY SYSTEM
KYB
Lens, Guide, Intraocular
66d
Cleared
Jul 06, 1998
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
194d
Cleared
Jul 06, 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
126d
Cleared
Jul 06, 1998
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
63d
Cleared
Jun 24, 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
LPN
Accessories, Soft Lens Products
127d
Cleared
Jun 24, 1998
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT
LPL
Lenses, Soft Contact, Daily Wear
35d
Cleared
Jun 23, 1998
AUTOMATED CORNEAL TREPHINE
HRG
Engine, Trephine, Accessories, Ac-powered
92d
Cleared
Jun 23, 1998
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
HQC
Unit, Phacofragmentation
89d
Cleared
Jun 23, 1998
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
LPL
Lenses, Soft Contact, Daily Wear
78d
Cleared
Jun 22, 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392
LPN
Accessories, Soft Lens Products
84d
Cleared
Jun 17, 1998
MEDITEC LINK
HQF
Laser, Ophthalmic
90d
Cleared
Jun 09, 1998
QUITETIP
HQC
Unit, Phacofragmentation
74d
Cleared
Jun 01, 1998
STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
MSR
Tubing, Replacement, Phacofragmentation Unit
140d
Cleared
May 19, 1998
CATARACT LIQUEFRACTURE DEVICE
MUS
Fluidic, Phacoemulsification/phacofragmentation
113d
Cleared
May 19, 1998
OPHTHAVISION IMAGING SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
112d
Cleared
May 19, 1998
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
MPA
Endoilluminator
78d
Cleared
May 19, 1998
SOVEREIGN CATARACT EXTRACTION SYSTEM
KYG
Device, Irrigation, Ocular Surgery
53d
Cleared
May 15, 1998
EYE IRRIGATOR MODEL #2020
KYG
Device, Irrigation, Ocular Surgery
87d
Cleared
May 13, 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
LPL
Lenses, Soft Contact, Daily Wear
83d
Cleared
May 12, 1998
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13
MPA
Endoilluminator
90d
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