FDA 510(k) Ophthalmic Devices
About Ophthalmic Devices
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
5094
Total
5076
Cleared
109d
Avg days
1976
Since
146 Ophthalmic devices
Not Cleared
Sep 25, 2025
Essilor® Stellest®
QUR
Prescription Spectacle Lenses To Reduce The Progression Of Myopia
150d
Cleared
Sep 24, 2025
LenSx Laser System (8065000944)
OOE
Ophthalmic Femtosecond Laser
30d
Cleared
Sep 17, 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
160d
Cleared
Sep 16, 2025
ACCUJECT Injector Set 2.1-1P (LP604590)
MSS
Folders And Injectors, Intraocular Lens (iol)
35d
Cleared
Sep 11, 2025
XTRA4
LYX
Media, Corneal Storage
135d
Cleared
Sep 10, 2025
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
111d
Cleared
Sep 04, 2025
Optina-4C (MHRC-C1N)
HKI
Camera, Ophthalmic, Ac-powered
175d
Cleared
Aug 14, 2025
3nethra neo HD FA
HKI
Camera, Ophthalmic, Ac-powered
266d
Cleared
Aug 08, 2025
MICOR 700 with Auto I/A
HQC
Unit, Phacofragmentation
281d
Cleared
Aug 01, 2025
MINI VP1 (PL67_F)
LRX
Case, Contact Lens
162d
Cleared
Jul 30, 2025
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
LPL
Lenses, Soft Contact, Daily Wear
313d
Cleared
Jul 18, 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
OBO
Tomography, Optical Coherence
143d
Cleared
Jul 02, 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
197d
Cleared
Jun 23, 2025
Digital Prism Correction Feature (DPCF)
SCW
Digital Prismatic Correction
157d
Cleared
Jun 18, 2025
EyeQ nanoECP
HQF
Laser, Ophthalmic
264d
Cleared
Jun 11, 2025
MICOR 700 System (N/A)
HQC
Unit, Phacofragmentation
267d
Cleared
May 12, 2025
SPECTRALIS HRA+OCT and variants
OBO
Tomography, Optical Coherence
49d
Cleared
Apr 30, 2025
Resolve Fundus Camera
HKI
Camera, Ophthalmic, Ac-powered
55d
Cleared
Apr 28, 2025
LenSx Laser System (8065998162)
OOE
Ophthalmic Femtosecond Laser
131d
Cleared
Apr 22, 2025
OcuMet Beacon (OCUB100)
MYC
Ophthalmoscope, Laser, Scanning
295d
Cleared
Apr 17, 2025
CLARUS (700)
QER
Camera, Ophthalmic, Slit-scanning
120d
Cleared
Apr 17, 2025
miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
LPL
Lenses, Soft Contact, Daily Wear
276d
Cleared
Apr 15, 2025
TearCare MGX System
ORZ
Eyelid Thermal Pulsation System
211d
Cleared
Apr 10, 2025
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
LPL
Lenses, Soft Contact, Daily Wear
108d
Cleared
Apr 09, 2025
Luminopia
QQU
Digital Therapy Device For Amblyopia
118d
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