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
2900 Ophthalmic devices
Cleared
Jul 25, 1991
LANDERS THREE STRUT VITRECTOMY LENS RING
HNH
Ring, Ophthalmic (flieringa)
71d
Cleared
Jun 25, 1991
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
HKX
Tonometer, Ac-powered
69d
Cleared
Jun 25, 1991
GEMINI OPHTHALMIC SURGERY SYSTEM
HQC
Unit, Phacofragmentation
63d
Cleared
Jun 25, 1991
MAINSTER HIGH MAGNIFICATION LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
27d
Cleared
Jun 17, 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
HKI
Camera, Ophthalmic, Ac-powered
76d
Cleared
May 24, 1991
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
HQF
Laser, Ophthalmic
87d
Cleared
May 22, 1991
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
HJO
Biomicroscope, Slit-lamp, Ac-powered
76d
Cleared
May 22, 1991
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
HNO
Keratome, Ac-powered
72d
Cleared
Apr 26, 1991
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
50d
Cleared
Apr 25, 1991
COMPAC(TM) DIODE LASERS
HQF
Laser, Ophthalmic
191d
Cleared
Apr 10, 1991
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
HOZ
Sponge, Ophthalmic
49d
Cleared
Mar 15, 1991
KRUPIN EYE VALVE WITH DISK
KYF
Implant, Eye Valve
85d
Cleared
Mar 04, 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
HQF
Laser, Ophthalmic
20d
Cleared
Feb 26, 1991
VITREORETINAL INFUSION CANNULA
HMX
Cannula, Ophthalmic
175d
Cleared
Feb 11, 1991
CENTAURI
HQF
Laser, Ophthalmic
88d
Cleared
Jan 28, 1991
NMR-K FUNDUS LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
10d
Cleared
Jan 22, 1991
STORZ DRAEGER ROTOR KERATOME
HNO
Keratome, Ac-powered
89d
Cleared
Dec 05, 1990
SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
HQC
Unit, Phacofragmentation
89d
Cleared
Dec 05, 1990
SITE PHACOEMULSIFICATION HANDPIECE
HQC
Unit, Phacofragmentation
84d
Cleared
Nov 21, 1990
SITE DIAPHRAGM CASSETTE
KYG
Device, Irrigation, Ocular Surgery
70d
Cleared
Nov 19, 1990
OPHTHASONIC A/P III
HPY
Unit, Electrolysis, Battery-powered, Ophthalmic
97d
Cleared
Nov 05, 1990
MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
HQQ
Apparatus, Cautery, Radiofrequency, Battery-powered
75d
Cleared
Oct 11, 1990
SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
HPS
Unit, Cryophthalmic
79d
Cleared
Jul 31, 1990
VISI-DRAPE OPHTHALMIC DRAPES
HMY
Keratome, Battery-powered
32d
Cleared
Jul 27, 1990
AR-1600G AUTO-REFRACTOMETER
HKO
Refractometer, Ophthalmic
52d
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