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
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
Cleared
Sep 06, 2024
VISULAS combi
HQF
Laser, Ophthalmic
269d
Cleared
Aug 22, 2024
iCare ALTIUS CW
NFJ
System, Image Management, Ophthalmic
245d
Cleared
Aug 16, 2024
BOSS™
MXK
Device, Analysis, Anterior Segment
613d
Cleared
Aug 14, 2024
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Aug 14, 2024
BostonSight® Specialty Lenses
HQD
Lens, Contact (other Material) - Daily
75d
Cleared
Aug 08, 2024
Luminopia
QQU
Digital Therapy Device For Amblyopia
261d
Cleared
Aug 05, 2024
Midfield Light Pipe, 23ga (3269.M06-00)
MPA
Endoilluminator
265d
Cleared
Jul 26, 2024
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
HQC
Unit, Phacofragmentation
186d
Cleared
Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
OBO
Tomography, Optical Coherence
89d
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