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
Jan 17, 1995
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
HQX
Implant, Orbital, Extra-ocular
88d
Cleared
Dec 19, 1994
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
76d
Cleared
Nov 28, 1994
STORZ PHACO AND FRAG HANDPIECES
HQC
Unit, Phacofragmentation
350d
Cleared
Nov 22, 1994
KEELER MULTILASE 3000
HQF
Laser, Ophthalmic
202d
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 14, 1994
ORTHOMET LHMC FEMORAL STEM
HMC
Monitor, Eye Movement, Diagnostic
556d
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
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 04, 1994
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
94d
Cleared
Aug 04, 1994
CIBA VISION(R) CONTACT LENS CASE
LRX
Case, Contact Lens
34d
Cleared
Jul 15, 1994
NIDEK MODEL VT-4000, MODIFICATION
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
198d
Cleared
Jul 12, 1994
AUTO REFF-30
HKO
Refractometer, Ophthalmic
158d
Cleared
Jul 01, 1994
PSB PREPERITONEAL STRUCTURE BALLOON
GCJ
Laparoscope, General & Plastic Surgery
28d
Cleared
Jun 09, 1994
DAILY WEAR SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
73d
Cleared
Jun 06, 1994
WELCH ALLYN GLAUCOMA DETECTOR
HOO
Perimeter, Ac-powered
60d
Cleared
Jun 03, 1994
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
HLJ
Ophthalmoscope, Battery-powered
36d
Cleared
May 27, 1994
BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
66d
Cleared
May 17, 1994
FIBEROPTIC ILLUMINATED INSTRUMENTS
HJM
Transilluminator, Ac-powered
259d
Cleared
Apr 29, 1994
SHAIDS PROTECTIVE GLASSES
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
459d
Cleared
Apr 01, 1994
OSHER SURGICAL GONIO/POSTERIOR POLE LENS
HKS
Prism, Gonioscopic
150d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices