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
5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1303 Ophthalmic devices
Cleared
Nov 27, 1984
MENDEZ U/S CYSTOTOME
HQC
Unit, Phacofragmentation
91d
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 08, 1984
EZ EYE DROP AID
185d
Cleared
Nov 05, 1984
AMER. EDWARDS LAB FLEXISCOPE
HRK
Table, Instrument, Manual, Ophthalmic
139d
Cleared
Oct 05, 1984
CANON AUTOREF R-10
HKO
Refractometer, Ophthalmic
154d
Cleared
Oct 05, 1984
NIDEK DIGITAL KERATOMETER
HQL
Intraocular Lens
74d
Cleared
Oct 05, 1984
CANON 60 FUNDUS CAMERA CF-60U
HKI
Camera, Ophthalmic, Ac-powered
65d
Cleared
Oct 05, 1984
VISITEC FLIERINGA-LEGRAND FIXATION RING
HMH
Rack, Skiascopic
52d
Cleared
Oct 05, 1984
VISITEC EYE SPECULUM
HNC
Specula, Ophthalmic
52d
Cleared
Oct 05, 1984
CONCEPT FIBER OPTIC CANALICULUS INTUBA
HNL
Probe, Lachrymal
29d
Cleared
Aug 07, 1984
ROOTMAN ORBITAL SURGERY INSTRUMENT SET
HNR
Forceps, Ophthalmic
27d
Cleared
Jun 26, 1984
MODEL 4000 MD-YAG LASER FOR MALIGNANT
HQF
Laser, Ophthalmic
7d
Cleared
Jun 19, 1984
CAT 100
HKX
Tonometer, Ac-powered
116d
Cleared
Jun 01, 1984
MICROSURGICAL KNIFE
HNN
Knife, Ophthalmic
18d
Cleared
May 22, 1984
STORZ UNIVERSAL EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
34d
Cleared
May 16, 1984
FLATPACK CARRYING CASE
44d
Cleared
May 09, 1984
LACHRYMAL PROBES-VARIOUS
HNW
Dilator, Lachrymal
61d
Cleared
May 09, 1984
OPHTHALMIC CURETTE-VARIOUS
HNZ
Curette, Ophthalmic
61d
Cleared
Apr 25, 1984
MONITOR CO2 LASER SURGICAL SYSTEM
HQF
Laser, Ophthalmic
103d
Cleared
Mar 29, 1984
DOUBLE & SINGLE TANTALUM CLIPS
HQW
Clip, Tantalum, Ophthalmic
70d
Cleared
Mar 19, 1984
OPHTEC RUST RING REMOVER
HOG
Burr, Corneal, Battery-powered
97d
Cleared
Mar 16, 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
HQF
Laser, Ophthalmic
109d
Cleared
Mar 16, 1984
MICRO FORCEPS
HNR
Forceps, Ophthalmic
94d
Cleared
Mar 16, 1984
EYE SPONGE OR SPEAR
HOZ
Sponge, Ophthalmic
94d
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