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
Dec 02, 1987
CAPTAIN POWER SUNGLASSES STYLES: #1020 #1021
HQY
Sunglasses (non-prescription Including Photosensitive)
63d
Cleared
Nov 25, 1987
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
LPN
Accessories, Soft Lens Products
33d
Cleared
Nov 24, 1987
IRAS GLARE TESTER
HLJ
Ophthalmoscope, Battery-powered
56d
Cleared
Nov 13, 1987
KEELER CTU CRYO SYSTEM
HPS
Unit, Cryophthalmic
81d
Cleared
Nov 02, 1987
TKS 4000 AUTO PERIMETER
HPT
Perimeter, Automatic, Ac-powered
84d
Cleared
Nov 02, 1987
OBF MODEL 115 COMPUTER TONOMETER SYSTEM
HKX
Tonometer, Ac-powered
68d
Cleared
Nov 02, 1987
LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT
HPZ
Implant, Eye Sphere
60d
Cleared
Nov 02, 1987
RICHMOND VISUAL FIELD SCREENER
HOO
Perimeter, Ac-powered
38d
Cleared
Nov 02, 1987
TONOMETER TAPES
HKX
Tonometer, Ac-powered
38d
Cleared
Nov 02, 1987
MODIFIED RETINAL CAMERA MODEL CR4-45NM
HKI
Camera, Ophthalmic, Ac-powered
31d
Cleared
Oct 29, 1987
OPHTHALAS DYE OPHTHALMIC LASER
HQF
Laser, Ophthalmic
62d
Cleared
Oct 28, 1987
READING CHARTS-CARDS (DISTANCE AND NEARPOINT)
HOX
Chart, Visual Acuity
33d
Cleared
Oct 28, 1987
JACKSON CROSS CYLINDER TEST
HOR
Simulatan (including Crossed Cylinder)
33d
Cleared
Oct 28, 1987
HEAD & CHIN RESTS
HRH
Trephine, Manual, Ophthalmic
34d
Cleared
Oct 28, 1987
TANGENT SCREEN
HOJ
Screen, Tangent, Target
33d
Cleared
Oct 23, 1987
GORSK INSTRUMENT REST
HMG
Stand, Instrument, Ophthalmic, Non-powered
56d
Cleared
Oct 15, 1987
NIDEK ADC-8000 LASER SYSTEM
HQF
Laser, Ophthalmic
87d
Cleared
Oct 15, 1987
W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION
LPN
Accessories, Soft Lens Products
77d
Cleared
Oct 05, 1987
INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17
HQZ
Frame, Spectacle
91d
Cleared
Oct 05, 1987
AR DIACOAT SINGLE VISION LENSES
HQG
Lens, Spectacle, Non-custom (prescription)
49d
Cleared
Oct 02, 1987
WINK-EASE PERSONAL PROTECTIVE EYEWEAR
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
22d
Cleared
Sep 30, 1987
OXFORD RETRO-ILLUMINATION CATARACT CAMERA
HKI
Camera, Ophthalmic, Ac-powered
51d
Cleared
Sep 30, 1987
NONPRESCRIPTION SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
16d
Cleared
Sep 29, 1987
OPTI-ZYME(R)
LPN
Accessories, Soft Lens Products
29d
Cleared
Sep 21, 1987
OPHTHALMIC PHACO-BLADE
HNN
Knife, Ophthalmic
28d
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