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
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
Cleared
Oct 11, 2024
SPECTRALIS with Flex Module
OBO
Tomography, Optical Coherence
168d
Cleared
Oct 10, 2024
EyeGility™ Inserter for Preloaded enVista IOLs
MSS
Folders And Injectors, Intraocular Lens (iol)
59d
Cleared
Oct 09, 2024
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
LRX
Case, Contact Lens
271d
Cleared
Oct 08, 2024
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
57d
Not Cleared
Sep 30, 2024
OcuCool
QZQ
592d
Cleared
Sep 27, 2024
iCare ST500 (TA04)
HKY
Tonometer, Manual
128d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices