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
Jul 16, 1992
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
94d
Cleared
Jul 09, 1992
ZIESS ENDOPROBE
HQB
Photocoagulator And Accessories
31d
Cleared
Jul 02, 1992
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
97d
Cleared
Jun 09, 1992
STERILE/SINGLE USE OPHTHALMIC CONFORMERS
HQN
Conformer, Ophthalmic
88d
Cleared
May 18, 1992
DISPOSABLE POSTERIOR MICROSCISSORS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
90d
Cleared
Mar 30, 1992
STERILE/SINGLE USE EYE SPHERE IMPLANTS
HPZ
Implant, Eye Sphere
21d
Cleared
Mar 19, 1992
AQUEOUS PARACENTESIS PIPET
KYG
Device, Irrigation, Ocular Surgery
86d
Cleared
Mar 13, 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
81d
Cleared
Feb 24, 1992
VISITEC CANALICULAR STENT
LZU
Plug, Punctum
62d
Cleared
Jan 23, 1992
CANDELA RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
182d
Cleared
Dec 24, 1991
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
210d
Cleared
Dec 23, 1991
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
HLI
Ophthalmoscope, Ac-powered
194d
Cleared
Dec 09, 1991
PEDIATRIC VITRECTOMY LENS SET
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
90d
Cleared
Nov 13, 1991
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
61d
Cleared
Oct 15, 1991
NIDEK MODEL NT-1000
HKX
Tonometer, Ac-powered
89d
Cleared
Oct 02, 1991
EYE BUBBLE
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
126d
Cleared
Oct 02, 1991
UNIDIRECTIONAL OCCLUDER
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
72d
Cleared
Aug 21, 1991
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS
MLP
Keratoprosthesis, Temporary Implant, Surgical Use
175d
Cleared
Aug 09, 1991
TBD KERATOSCOPE
HLQ
Keratoscope, Ac-powered
87d
Cleared
Aug 07, 1991
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
78d
Cleared
Aug 07, 1991
LANDERS NOTCHED VITRECTOMY LENS RING
HNH
Ring, Ophthalmic (flieringa)
77d
Cleared
Aug 07, 1991
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING
HNH
Ring, Ophthalmic (flieringa)
77d
Cleared
Jul 25, 1991
TBD, LENS MEASURING DEVICE
HRJ
Table, Instrument, Powered, Ophthalmic
72d
Cleared
Jul 25, 1991
LANDERS THREE STRUT VITRECTOMY LENS RING
HNH
Ring, Ophthalmic (flieringa)
71d
Cleared
Jun 25, 1991
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
HKX
Tonometer, Ac-powered
69d
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