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
5100
Total
5082
Cleared
170d
Avg (2y)
1976
Since
492 Ophthalmic devices
Cleared
Apr 10, 2018
ACUVUE OASYS (senofilcon A) with Photochromic Additive
LPL
Lenses, Soft Contact, Daily Wear
67d
Cleared
Apr 10, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
Apr 05, 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
HKI
Camera, Ophthalmic, Ac-powered
52d
Cleared
Apr 03, 2018
OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
LPL
Lenses, Soft Contact, Daily Wear
96d
Cleared
Mar 27, 2018
LenSx Laser System
OOE
Ophthalmic Femtosecond Laser
118d
Cleared
Mar 27, 2018
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
MRC
Products, Contact Lens Care, Rigid Gas Permeable
50d
Cleared
Mar 16, 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG
HQD
Lens, Contact (other Material) - Daily
53d
Cleared
Mar 16, 2018
Frigitronics adapter
HRN
Unit, Cryophthalmic, Ac-powered
51d
Cleared
Mar 14, 2018
Specular Microscope CEM-530
NQE
Microscope, Specular
75d
Cleared
Mar 09, 2018
CATS Tonometer Prism
HKY
Tonometer, Manual
77d
Cleared
Mar 02, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
128d
Cleared
Feb 28, 2018
P200TE
OBO
Tomography, Optical Coherence
86d
Cleared
Feb 23, 2018
Ophthalmic Software Platform RX
NFJ
System, Image Management, Ophthalmic
84d
Cleared
Feb 22, 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
Jan 19, 2018
EM-4000 Specular Microscope
NQE
Microscope, Specular
260d
Cleared
Jan 19, 2018
DRI OCT Triton
OBO
Tomography, Optical Coherence
112d
Cleared
Dec 11, 2017
Crystalsert Lens Delivery System
MSS
Folders And Injectors, Intraocular Lens (iol)
28d
Cleared
Nov 02, 1999
KSEA DE LA PLAZA BLEPHAROPLASTY SET
HNI
Retractor, Ophthalmic
179d
Cleared
Apr 29, 1994
SHAIDS PROTECTIVE GLASSES
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
459d
Cleared
Aug 03, 1993
BIO-PEN SRK II CALCULATOR
LQB
Medical Computers And Software For Ophthalmic Use
427d
Cleared
Jun 22, 1993
TIP & MEMBRANE ASSEMBLY
HKX
Tonometer, Ac-powered
483d
Cleared
Aug 05, 1992
CYLINDER OF GAS, CAN OF GAS (CC12F2)
HKX
Tonometer, Ac-powered
121d
Cleared
Oct 31, 1989
BIO-RAD MODULAR AIR COMPRESSOR
HKX
Tonometer, Ac-powered
47d
Cleared
Apr 01, 1988
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
HOX
Chart, Visual Acuity
45d
Cleared
Feb 20, 1987
DIGILAB MODEL 1500 PERIMETER
HPT
Perimeter, Automatic, Ac-powered
39d
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