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
Jan 23, 1991
JMB TRADING COMPANY SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
134d
Cleared
Jan 22, 1991
STORZ DRAEGER ROTOR KERATOME
HNO
Keratome, Ac-powered
89d
Cleared
Jan 18, 1991
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
HKO
Refractometer, Ophthalmic
86d
Cleared
Dec 26, 1990
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
HQC
Unit, Phacofragmentation
76d
Cleared
Dec 21, 1990
THE VISONIC DOME(TM)
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
213d
Cleared
Dec 21, 1990
CHIROFLEX FORCEPS
KYB
Lens, Guide, Intraocular
135d
Cleared
Dec 18, 1990
TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
HQF
Laser, Ophthalmic
140d
Cleared
Dec 13, 1990
PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
LXS
Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
252d
Cleared
Dec 07, 1990
CHILDRENS SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
204d
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 21, 1990
NONPRESCRIPTION SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
65d
Cleared
Nov 19, 1990
OPHTHASONIC A/P III
HPY
Unit, Electrolysis, Battery-powered, Ophthalmic
97d
Cleared
Nov 05, 1990
SOLARSHIELDS ENCORE
HQY
Sunglasses (non-prescription Including Photosensitive)
97d
Cleared
Nov 05, 1990
MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
HQQ
Apparatus, Cautery, Radiofrequency, Battery-powered
75d
Cleared
Nov 05, 1990
CHILDRENS SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
54d
Cleared
Oct 26, 1990
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
64d
Cleared
Oct 26, 1990
POST MYDRIATIC SPECTACLES
HQY
Sunglasses (non-prescription Including Photosensitive)
17d
Cleared
Oct 23, 1990
SUNSHADES, ACRYLIC LENSES #SG-01
HQY
Sunglasses (non-prescription Including Photosensitive)
154d
Cleared
Oct 19, 1990
CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
25d
Cleared
Oct 17, 1990
KERATOME
HNO
Keratome, Ac-powered
54d
Cleared
Oct 16, 1990
OPTIMED GLAUCOMA PRESSURE REGULATOR
KYF
Implant, Eye Valve
76d
Cleared
Oct 11, 1990
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
147d
Cleared
Oct 11, 1990
SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
HPS
Unit, Cryophthalmic
79d
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