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
490 Ophthalmic devices
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
Cleared
Dec 13, 2024
Anterion
OBO
Tomography, Optical Coherence
253d
Cleared
Dec 09, 2024
Verily Numetric Retinal Camera
HKI
Camera, Ophthalmic, Ac-powered
109d
Cleared
Dec 04, 2024
Alcon 27GA Chandelier (8065000252)
MPA
Endoilluminator
132d
Cleared
Nov 04, 2024
Tixel i (TXLI0001)
ORZ
Eyelid Thermal Pulsation System
256d
Not Cleared
Nov 04, 2024
Valeda Light Delivery System
SDE
Light Based Device For Dry Age-related Macular Degeneration
326d
Cleared
Nov 01, 2024
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
HQD
Lens, Contact (other Material) - Daily
80d
Cleared
Oct 25, 2024
LYNX Photocoagulator
HQF
Laser, Ophthalmic
73d
Cleared
Oct 25, 2024
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia
LPL
Lenses, Soft Contact, Daily Wear
205d
Cleared
Oct 22, 2024
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
HQD
Lens, Contact (other Material) - Daily
159d
Cleared
Oct 21, 2024
Digital Prism Correction Feature (DPCF)
SCW
Digital Prismatic Correction
98d
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