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
2899 Ophthalmic devices
Cleared
Sep 30, 1992
TONOSHIELD TONOMETER SHIELD
HKY
Tonometer, Manual
58d
Cleared
Aug 31, 1992
MODIFIED SITE MACROBORE PHACO NEEDLE
HQC
Unit, Phacofragmentation
90d
Cleared
Aug 05, 1992
OPHTHALMIC SPONGES
HOZ
Sponge, Ophthalmic
191d
Cleared
Aug 05, 1992
CYLINDER OF GAS, CAN OF GAS (CC12F2)
HKX
Tonometer, Ac-powered
121d
Cleared
Jul 30, 1992
WOODLYN CLASSIC LENSMETER
HLM
Instrument, Measuring, Lens, Ac-powered
156d
Cleared
Jul 27, 1992
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
KYG
Device, Irrigation, Ocular Surgery
35d
Cleared
Jul 17, 1992
STERILE/SINGLE USE SYMBLEPHARON RING
HQN
Conformer, Ophthalmic
126d
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 30, 1992
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
HQC
Unit, Phacofragmentation
88d
Cleared
Jun 11, 1992
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
HQC
Unit, Phacofragmentation
345d
Cleared
Jun 09, 1992
STERILE/SINGLE USE OPHTHALMIC CONFORMERS
HQN
Conformer, Ophthalmic
88d
Cleared
Jun 03, 1992
IOLAB POWER I.V. POLE
HQC
Unit, Phacofragmentation
85d
Cleared
May 18, 1992
DISPOSABLE POSTERIOR MICROSCISSORS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
90d
Cleared
May 08, 1992
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
88d
Cleared
May 07, 1992
TRIAL LENS SET
HPC
Set, Lens, Trial, Ophthalmic
90d
Cleared
May 07, 1992
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
HMX
Cannula, Ophthalmic
38d
Cleared
Mar 30, 1992
MENTOR HORIZON LOW VISION MAGNIFIER
HJG
System, Reading, Television, Closed-circuit
158d
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
PHACO 20/20 SYSTEM I
HQC
Unit, Phacofragmentation
81d
Cleared
Feb 24, 1992
VISITEC CANALICULAR STENT
LZU
Plug, Punctum
62d
Cleared
Feb 12, 1992
PHACO 3000 LINEAR
HQC
Unit, Phacofragmentation
69d
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