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
2878 Ophthalmic devices
Cleared
Jun 07, 2018
AT 030
HKY
Tonometer, Manual
69d
Cleared
May 30, 2018
Retia 2
MYC
Ophthalmoscope, Laser, Scanning
118d
Cleared
May 25, 2018
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
HQF
Laser, Ophthalmic
100d
Not Cleared
May 17, 2018
TrueTear Intranasal Tear Neurostimulator
QBR
Intranasal Electrostimulation Device For Dry Eye Symptoms
206d
Cleared
May 16, 2018
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
48d
Cleared
Apr 27, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal
LPL
Lenses, Soft Contact, Daily Wear
44d
Cleared
Apr 25, 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
HQD
Lens, Contact (other Material) - Daily
48d
Cleared
Apr 20, 2018
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
LPL
Lenses, Soft Contact, Daily Wear
74d
Cleared
Apr 13, 2018
VisuMax Femtosecond Laser
HNO
Keratome, Ac-powered
168d
Not Cleared
Apr 11, 2018
IDx-DR
PIB
Diabetic Retinopathy Detection Device
89d
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
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