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
2893 Ophthalmic devices
Cleared
May 06, 1997
SOLAR SPECS
HQY
Sunglasses (non-prescription Including Photosensitive)
64d
Cleared
May 06, 1997
ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT
MPA
Endoilluminator
57d
Cleared
May 06, 1997
CUSTOM OPTICAL SUNGLASS FRAMES
HQY
Sunglasses (non-prescription Including Photosensitive)
56d
Cleared
May 06, 1997
BARAKKA, INFERNO, STERLING, AND/OR ONE
HQY
Sunglasses (non-prescription Including Photosensitive)
54d
Cleared
May 06, 1997
CLASSIC MATCH
HQY
Sunglasses (non-prescription Including Photosensitive)
41d
Cleared
May 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
MSG
Ophthalmoscopes, Replacement Batteries, Hand-held
41d
Cleared
May 06, 1997
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN
HQY
Sunglasses (non-prescription Including Photosensitive)
33d
Cleared
May 06, 1997
ARROW COMPANY
HQY
Sunglasses (non-prescription Including Photosensitive)
26d
Cleared
May 06, 1997
SYNTEC, INC. DISPOSABLE BARE END FIBER
MPA
Endoilluminator
26d
Cleared
May 05, 1997
DISPOSABLE VITRECTOMY PROBE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
70d
Cleared
Apr 23, 1997
MONARCH IOL DELIVERY SYSTEM
KYB
Lens, Guide, Intraocular
110d
Cleared
Apr 23, 1997
PUNCTUAL OCCLUDER
LZU
Plug, Punctum
63d
Cleared
Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
LZU
Plug, Punctum
223d
Cleared
Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
LZU
Plug, Punctum
210d
Cleared
Apr 03, 1997
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
83d
Cleared
Apr 02, 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
89d
Cleared
Apr 02, 1997
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
65d
Cleared
Mar 31, 1997
VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
MPA
Endoilluminator
138d
Cleared
Mar 31, 1997
ACRYPAK FOLDER
KYB
Lens, Guide, Intraocular
97d
Cleared
Mar 31, 1997
ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY
MSG
Ophthalmoscopes, Replacement Batteries, Hand-held
67d
Cleared
Mar 31, 1997
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
HNO
Keratome, Ac-powered
56d
Cleared
Mar 31, 1997
STYLE EYES OPTICS
HQY
Sunglasses (non-prescription Including Photosensitive)
31d
Cleared
Mar 26, 1997
ORBSHOT KERATOMETER
MMQ
Topographer, Corneal, Ac-powered
110d
Cleared
Mar 25, 1997
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
LPL
Lenses, Soft Contact, Daily Wear
82d
Cleared
Mar 25, 1997
HEDGES CORNEAL WETTING PAK
KYG
Device, Irrigation, Ocular Surgery
70d
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