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
Jun 25, 1991
MAINSTER HIGH MAGNIFICATION LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
27d
Cleared
Jun 18, 1991
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
HPZ
Implant, Eye Sphere
106d
Cleared
Jun 17, 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
HKI
Camera, Ophthalmic, Ac-powered
76d
Cleared
Jun 17, 1991
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
35d
Cleared
Jun 10, 1991
COLLAGEN SHIELD, VARIOUS MODELS
MOE
Collagen Corneal Shield
161d
Cleared
Jun 06, 1991
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
LZU
Plug, Punctum
184d
Cleared
Jun 06, 1991
ORIGINALS
HQY
Sunglasses (non-prescription Including Photosensitive)
73d
Cleared
May 28, 1991
URAM OPHTHALMIC LASER ENDOSCOPE
HQF
Laser, Ophthalmic
109d
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
May 22, 1991
SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.
HQY
Sunglasses (non-prescription Including Photosensitive)
33d
Cleared
May 14, 1991
PATHFINDER
HPG
Aid, Vision, Electronic, Battery-powered
90d
Cleared
May 13, 1991
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
LZU
Plug, Punctum
70d
Cleared
May 06, 1991
OPTHLAMIC FRAMES
HQZ
Frame, Spectacle
62d
Cleared
May 06, 1991
SPECTACLE FRAME
HQZ
Frame, Spectacle
41d
Cleared
May 01, 1991
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
91d
Cleared
May 01, 1991
OPHTA SIL (R), LACHRYMAL INTUBATION SETS
OKS
Lacrimal Stents And Intubation Sets
58d
Cleared
Apr 26, 1991
SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2
HQY
Sunglasses (non-prescription Including Photosensitive)
73d
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
LOW VISION ENHANCEMENT SYSTEM (LVES)
HPG
Aid, Vision, Electronic, Battery-powered
89d
Cleared
Apr 10, 1991
OPTICAL FRAME
HQZ
Frame, Spectacle
85d
Cleared
Apr 10, 1991
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
HOZ
Sponge, Ophthalmic
49d
Cleared
Apr 08, 1991
SCITECH BI-MANUAL ADAPTER CLIPS
HQQ
Apparatus, Cautery, Radiofrequency, Battery-powered
89d
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