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
Nov 29, 1984
VISITEC MAGNIFYING SPECTACLES
HOI
Spectacle, Magnifying
44d
Cleared
Nov 28, 1984
COLOR OPTIC CORNEAL EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
48d
Cleared
Nov 27, 1984
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
HQC
Unit, Phacofragmentation
120d
Cleared
Nov 27, 1984
IOCARE IRRIGATION/ASPIRATION PACK
HQC
Unit, Phacofragmentation
99d
Cleared
Nov 27, 1984
IOCARE PHACOEMULSIFICATION PACK
HQC
Unit, Phacofragmentation
99d
Cleared
Nov 27, 1984
IOCARE ULTRASONIC TITANIUM TIPS
HQC
Unit, Phacofragmentation
99d
Cleared
Nov 27, 1984
MENDEZ U/S CYSTOTOME
HQC
Unit, Phacofragmentation
91d
Cleared
Nov 27, 1984
POCKET OPHTHALMOSCOPE GH
HLJ
Ophthalmoscope, Battery-powered
55d
Cleared
Nov 27, 1984
CUSTOM LITE
HQG
Lens, Spectacle, Non-custom (prescription)
21d
Cleared
Nov 21, 1984
OPERAID SURGICAL DRAIN
HOZ
Sponge, Ophthalmic
210d
Cleared
Nov 21, 1984
OPERAID NUCLEUS
KYG
Device, Irrigation, Ocular Surgery
204d
Cleared
Nov 21, 1984
AUTOMATED INTRAOCULAR SCISSORS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
149d
Cleared
Nov 21, 1984
BRILLETTE MODEL
HOI
Spectacle, Magnifying
124d
Cleared
Nov 21, 1984
SITE ANTERIOR CAPSULOTOMER
HMX
Cannula, Ophthalmic
111d
Cleared
Nov 21, 1984
HESLIN DISPOS. TUBING SET
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
111d
Cleared
Nov 21, 1984
CRISTY/COTE
HQG
Lens, Spectacle, Non-custom (prescription)
106d
Cleared
Nov 21, 1984
MAMIYA SLIT LAMP P-1
HLI
Ophthalmoscope, Ac-powered
106d
Cleared
Nov 21, 1984
BINOCULAR INDIRECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
90d
Cleared
Nov 21, 1984
CILCOR OPHTHALMIC INSTRUMENTS
HNR
Forceps, Ophthalmic
41d
Cleared
Nov 21, 1984
SHURE GRIP TYING FORCEPS
HNR
Forceps, Ophthalmic
29d
Cleared
Nov 19, 1984
BAILEY LENS SHOOTER
KYB
Lens, Guide, Intraocular
208d
Cleared
Nov 19, 1984
LENSKEEPER LENS CARRYING CASE
HPX
Lens, Contact (polymethylmethacrylate)
84d
Cleared
Nov 19, 1984
EPISCLERAL VENOUS PRESSURE
HKX
Tonometer, Ac-powered
84d
Cleared
Nov 08, 1984
EZ EYE DROP AID
185d
Cleared
Nov 08, 1984
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
HQB
Photocoagulator And Accessories
28d
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