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
Jun 29, 2018
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
Jun 27, 2018
CALLISTO eye
NFJ
System, Image Management, Ophthalmic
86d
Cleared
Jun 27, 2018
Alleye
HOQ
Grid, Amsler
83d
Cleared
Jun 25, 2018
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA
LPL
Lenses, Soft Contact, Daily Wear
47d
Cleared
Jun 13, 2018
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
LPL
Lenses, Soft Contact, Daily Wear
54d
Cleared
Jun 08, 2018
Nexy
HKI
Camera, Ophthalmic, Ac-powered
126d
Cleared
Jun 08, 2018
Avanti
OBO
Tomography, Optical Coherence
86d
Cleared
Jun 08, 2018
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
Jun 08, 2018
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
53d
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
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