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
May 14, 1986
CANON AUTO REF KERATOMETER RK-1
29d
Cleared
May 14, 1986
CANON AUTO ACUITOMETER CV-10
HOX
Chart, Visual Acuity
29d
Cleared
May 14, 1986
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
HMR
Marker, Ocular
20d
Cleared
Apr 24, 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
HNR
Forceps, Ophthalmic
29d
Cleared
Apr 15, 1986
STORZ/MAZZACCO LENS FORCEP
HNR
Forceps, Ophthalmic
35d
Cleared
Apr 15, 1986
LM-850 AUTOMATIC LENSMETER
HLM
Instrument, Measuring, Lens, Ac-powered
26d
Cleared
Apr 09, 1986
AR-1100 AUTOMATIC REFRACTOR
HKO
Refractometer, Ophthalmic
20d
Cleared
Apr 04, 1986
BAUSCH & LOMB LENS CARRYING CASE
HPX
Lens, Contact (polymethylmethacrylate)
114d
Cleared
Apr 04, 1986
AR-1600 AUTOMATIC REFRACTOR
HKO
Refractometer, Ophthalmic
15d
Cleared
Apr 04, 1986
NIDEK KM-800 AUTO KERATOMETER
HLQ
Keratoscope, Ac-powered
15d
Cleared
Apr 04, 1986
AR-1000 AUTOMATIC REFRACTOR
HKO
Refractometer, Ophthalmic
15d
Cleared
Mar 05, 1986
STORZ E9040 & E9046 DIAMOND KNIVES
HNN
Knife, Ophthalmic
78d
Cleared
Feb 27, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
HKI
Camera, Ophthalmic, Ac-powered
63d
Cleared
Feb 27, 1986
DIGILAB CAMBRIDGE PERIMETER
HOO
Perimeter, Ac-powered
45d
Cleared
Feb 07, 1986
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
HMX
Cannula, Ophthalmic
87d
Cleared
Feb 07, 1986
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
LXP
Plug, Scleral
87d
Cleared
Feb 07, 1986
NIDEK AC-2000 LASER SYSTEM
HQB
Photocoagulator And Accessories
35d
Cleared
Feb 04, 1986
STORZ DAISY
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
84d
Cleared
Feb 04, 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
HQF
Laser, Ophthalmic
56d
Cleared
Dec 30, 1985
KEELER-COMPACT CRYO SYSTEM
HQA
Unit, Cryotherapy, Ophthalmic
59d
Cleared
Dec 30, 1985
SERIES 25 SLIMLINE CRYO PROBES
HQA
Unit, Cryotherapy, Ophthalmic
56d
Cleared
Dec 27, 1985
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
HQC
Unit, Phacofragmentation
58d
Cleared
Dec 16, 1985
STORZ IAS DISPOSABLE PACK
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
123d
Cleared
Dec 13, 1985
HESSBURG LIGHT GUARD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
148d
Cleared
Dec 13, 1985
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
79d
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