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
May 09, 2000
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES
HMX
Cannula, Ophthalmic
88d
Cleared
May 08, 2000
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
MPA
Endoilluminator
90d
Cleared
May 08, 2000
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
MRH
Pump, Infusion, Ophthalmic
90d
Cleared
May 05, 2000
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
HNO
Keratome, Ac-powered
25d
Cleared
May 04, 2000
EYECAP IMAGING SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
90d
Cleared
May 02, 2000
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
HKO
Refractometer, Ophthalmic
90d
Cleared
Apr 28, 2000
OPTI-FREE EXPRESS LENS DROPS
MRC
Products, Contact Lens Care, Rigid Gas Permeable
81d
Cleared
Apr 21, 2000
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
MML
Weights, Eyelid, External
14d
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
FLUROPERM 60-OK, PARAGON HDS-OK
MUW
Lens, Contact (orthokeratology)
84d
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 12, 2000
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
MML
Weights, Eyelid, External
85d
Cleared
Apr 11, 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
MRC
Products, Contact Lens Care, Rigid Gas Permeable
84d
Cleared
Apr 10, 2000
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
MQU
Ocular Peg
82d
Cleared
Mar 31, 2000
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
HLI
Ophthalmoscope, Ac-powered
25d
Cleared
Mar 23, 2000
REICHERT CT200 CONTACT TONOMETER
HKY
Tonometer, Manual
52d
Cleared
Mar 21, 2000
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT
LPL
Lenses, Soft Contact, Daily Wear
43d
Cleared
Mar 21, 2000
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)
LPL
Lenses, Soft Contact, Daily Wear
33d
Cleared
Mar 20, 2000
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C
LPL
Lenses, Soft Contact, Daily Wear
39d
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
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