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
Jul 31, 1981
OPHTHALMIC SCISSORS
HNF
Scissors, Ophthalmic
88d
Cleared
Jul 28, 1981
KOI LACRIMAL INTUBATION SYSTEM
HMX
Cannula, Ophthalmic
11d
Cleared
Jul 28, 1981
BLADE GAUGE
HOE
Caliper, Ophthalmic
11d
Cleared
Jul 16, 1981
EYE CARE TRAY
83d
Cleared
Jul 02, 1981
BARNES-HIND SPECTACLE LENS CLEANER
HQG
Lens, Spectacle, Non-custom (prescription)
30d
Cleared
Jun 26, 1981
ANIS LENS IMPLANT FORCEPS #2
HNR
Forceps, Ophthalmic
14d
Cleared
Jun 16, 1981
ANIS GUIDING CANNULA
HMX
Cannula, Ophthalmic
25d
Cleared
Jun 11, 1981
OPTOCRYL CONTACT LENS BLANKS
HPX
Lens, Contact (polymethylmethacrylate)
143d
Cleared
Jun 09, 1981
PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM
HLX
Photostimulator, Ac-powered
85d
Cleared
May 15, 1981
ANIS IRRIGATING SPATULA
HND
Spatula, Ophthalmic
38d
Cleared
May 15, 1981
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ
HOS
Projector, Ophthalmic
17d
Cleared
May 13, 1981
KEELER/KONAN SPECULAR MICROSCOPE
HJO
Biomicroscope, Slit-lamp, Ac-powered
84d
Cleared
Apr 23, 1981
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR
HKO
Refractometer, Ophthalmic
226d
Cleared
Apr 23, 1981
MULTIMICRO SURGICAL CAUTERY
HQP
Unit, Cautery, Thermal, Battery-powered
108d
Cleared
Apr 23, 1981
MULTIPERFECTEMP CAUTERY
HQP
Unit, Cautery, Thermal, Battery-powered
108d
Cleared
Apr 23, 1981
REPLACABLE BATTERY PERFECTEMP CAUTERY
HQP
Unit, Cautery, Thermal, Battery-powered
108d
Cleared
Apr 23, 1981
EXETER OPERATING LOUPE
HOH
Spectacle, Operating (loupe), Ophthalmic
30d
Cleared
Apr 17, 1981
BARNES-HIND ROSE BENGAL OPHTHALMIC STR.
KYC
74d
Cleared
Apr 10, 1981
CHROMOPS FM-100 COLOR VISION TESTER
HIT
Tester, Color Vision
25d
Cleared
Apr 03, 1981
FASHION SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
94d
Cleared
Apr 03, 1981
EYEGLASS FRAMES
HQZ
Frame, Spectacle
60d
Cleared
Mar 17, 1981
X-VEE
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-powered
55d
Cleared
Mar 04, 1981
EYETECH-VISION SCREENING SYSTEM
HOX
Chart, Visual Acuity
71d
Cleared
Feb 27, 1981
FOX EYE SHIELDS
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
39d
Cleared
Feb 13, 1981
POLARIS SPECTACLE FRAMES & LENSES
HQY
Sunglasses (non-prescription Including Photosensitive)
169d
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