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
2898 Ophthalmic devices
Cleared
Nov 10, 1994
HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
HJM
Transilluminator, Ac-powered
618d
Cleared
Nov 08, 1994
MANDELKORN SUTURE LYSIS LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
452d
Cleared
Oct 31, 1994
RITCH NYLON SUTURE LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
482d
Cleared
Oct 20, 1994
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
86d
Cleared
Oct 14, 1994
ORTHOMET LHMC FEMORAL STEM
HMC
Monitor, Eye Movement, Diagnostic
556d
Cleared
Oct 11, 1994
PHACO TIPS FOR PHACO FRAGMENTATION MACHINES
HQC
Unit, Phacofragmentation
90d
Cleared
Sep 28, 1994
AUTOMATIC LENSOMETER
HLM
Instrument, Measuring, Lens, Ac-powered
273d
Cleared
Sep 28, 1994
WIRELESS CHART PROJECTOR,HCP-W 721
HOS
Projector, Ophthalmic
273d
Cleared
Sep 28, 1994
COMPREHENSIVE PHOROPTER, MDR-680
HKN
Refractor, Manual, Non-powered, Including Phoropter
273d
Cleared
Sep 23, 1994
DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
HJM
Transilluminator, Ac-powered
437d
Cleared
Sep 23, 1994
BIPOLAR ELECTROSURGICAL PENCIL
HQO
Unit, Cautery, Thermal, Ac-powered
88d
Cleared
Sep 15, 1994
IOLAB LACRIMAL DUCT CATHETER
OKS
Lacrimal Stents And Intubation Sets
318d
Cleared
Sep 02, 1994
PEREGRINE WIDE ANGLE LIGHT PIPE
HJM
Transilluminator, Ac-powered
219d
Cleared
Sep 02, 1994
MEDPOR SURGICAL IMPLANT MATERIAL
HPZ
Implant, Eye Sphere
57d
Cleared
Aug 29, 1994
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
HMR
Marker, Ocular
662d
Cleared
Aug 29, 1994
STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY
HPL
Device, Fixation, Ac-powered, Ophthalmic
509d
Cleared
Aug 29, 1994
50 DEGREE HRI PRISM LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
159d
Cleared
Aug 25, 1994
BOSTON(R) 7 - 30(ENFLUFOCON A)
HQD
Lens, Contact (other Material) - Daily
55d
Cleared
Aug 23, 1994
PEREGRINE PIC MINIPULATOR
KYG
Device, Irrigation, Ocular Surgery
209d
Cleared
Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
HLI
Ophthalmoscope, Ac-powered
57d
Cleared
Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A
HLI
Ophthalmoscope, Ac-powered
57d
Cleared
Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H
HLI
Ophthalmoscope, Ac-powered
57d
Cleared
Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
HLI
Ophthalmoscope, Ac-powered
57d
Cleared
Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
HLI
Ophthalmoscope, Ac-powered
57d
Cleared
Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
HLJ
Ophthalmoscope, Battery-powered
57d
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