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
2876 Ophthalmic devices
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
Cleared
Apr 03, 2025
Leos Laser and Endoscopy System
HQF
Laser, Ophthalmic
394d
Cleared
Mar 20, 2025
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
LPL
Lenses, Soft Contact, Daily Wear
265d
Cleared
Mar 17, 2025
MAIA (AHMACME001)
MYC
Ophthalmoscope, Laser, Scanning
125d
Cleared
Feb 14, 2025
VIA360™ Surgical System
MRH
Pump, Infusion, Ophthalmic
94d
Cleared
Feb 04, 2025
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
133d
Cleared
Jan 13, 2025
Precision1
LPL
Lenses, Soft Contact, Daily Wear
25d
Cleared
Dec 17, 2024
Sentinel Camera
HKI
Camera, Ophthalmic, Ac-powered
20d
Cleared
Dec 17, 2024
VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
125d
Cleared
Dec 16, 2024
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
LPL
Lenses, Soft Contact, Daily Wear
459d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices