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
May 09, 1984
LENS INSERTION GLIDE
KYB
Lens, Guide, Intraocular
83d
Cleared
May 09, 1984
CORNEAL SCLERAL LANCE
HNN
Knife, Ophthalmic
75d
Cleared
May 09, 1984
TSE-ANDERSON MODIFIED LACRIMAL GROOV
HNL
Probe, Lachrymal
75d
Cleared
May 09, 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
HQC
Unit, Phacofragmentation
64d
Cleared
May 09, 1984
LACHRYMAL PROBES-VARIOUS
HNW
Dilator, Lachrymal
61d
Cleared
May 09, 1984
OPHTHALMIC CURETTE-VARIOUS
HNZ
Curette, Ophthalmic
61d
Cleared
May 09, 1984
SPECTACLE INDIRECT OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
41d
Cleared
May 09, 1984
PANORAMIC LOUPES - VARIOUS
HLT
Preamplifier, Ac-powered, Ophthalmic
41d
Cleared
May 09, 1984
REPLACE-A-TIP RECHARG. LOW TEMP.
HQP
Unit, Cautery, Thermal, Battery-powered
37d
Cleared
May 09, 1984
REPLACE-A-TIP RECHARGEABLE HIGH TEMP
HQP
Unit, Cautery, Thermal, Battery-powered
37d
Cleared
Apr 26, 1984
OFTALMOGRAF
233d
Cleared
Apr 25, 1984
MONITOR CO2 LASER SURGICAL SYSTEM
HQF
Laser, Ophthalmic
103d
Cleared
Apr 24, 1984
PETRUS IOL GUIDE
KYB
Lens, Guide, Intraocular
105d
Cleared
Apr 23, 1984
ELMED WMC 10 AND BC 50 M/M
265d
Cleared
Apr 23, 1984
SURG A STAT FINE TIP 5
77d
Cleared
Apr 13, 1984
VISTECH VCTS 6000
HOX
Chart, Visual Acuity
81d
Cleared
Apr 13, 1984
SUN-LITE ONE MILLIMETER
73d
Cleared
Apr 13, 1984
SUN-LITE 1
71d
Cleared
Apr 05, 1984
IOCARE IRRIGATION & ASPIRATION PACK
HQC
Unit, Phacofragmentation
115d
Cleared
Apr 05, 1984
LASER LENS-VARIOUS MODELS
HQF
Laser, Ophthalmic
106d
Cleared
Apr 05, 1984
CYSTOTOME, 140-S
HNY
Cystotome
62d
Cleared
Apr 02, 1984
MULTIPLE
HQG
Lens, Spectacle, Non-custom (prescription)
195d
Cleared
Apr 02, 1984
MEDICAL LASER ENDOCOAGULATOR 5K
HQF
Laser, Ophthalmic
38d
Cleared
Mar 30, 1984
KEATES IRRIGATION/ASPIRATION/VITREOUS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
102d
Cleared
Mar 29, 1984
DOUBLE & SINGLE TANTALUM CLIPS
HQW
Clip, Tantalum, Ophthalmic
70d
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