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
5119
Total
5101
Cleared
169d
Avg (2y)
1976
Since
5119 Ophthalmic devices
Cleared
Apr 23, 2024
AEYE-DS
PIB
Diabetic Retinopathy Detection Device
106d
Cleared
Apr 17, 2024
Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
54d
Cleared
Apr 10, 2024
3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
OBO
Tomography, Optical Coherence
156d
Cleared
Apr 03, 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
29d
Cleared
Mar 08, 2024
RESCAN 700
OBO
Tomography, Optical Coherence
150d
Cleared
Mar 08, 2024
HP-OCT (HP-OCT)
HJO
Biomicroscope, Slit-lamp, Ac-powered
266d
Cleared
Mar 01, 2024
IMAGEnet6 Ophthalmic Data System
NFJ
System, Image Management, Ophthalmic
170d
Cleared
Feb 26, 2024
Stellaris Elite vision enhancement system
HQC
Unit, Phacofragmentation
228d
Cleared
Feb 21, 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
HQD
Lens, Contact (other Material) - Daily
145d
Cleared
Feb 09, 2024
CATS-L Tonometer™ Prism
HKY
Tonometer, Manual
50d
Cleared
Feb 06, 2024
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
LPL
Lenses, Soft Contact, Daily Wear
131d
Cleared
Jan 25, 2024
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Jan 25, 2024
MR Q
HQF
Laser, Ophthalmic
167d
Cleared
Jan 10, 2024
Centurion™ Vision System (Active Sentry™) (8065753057)
HQC
Unit, Phacofragmentation
30d
Cleared
Jan 03, 2024
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
421d
Cleared
Dec 29, 2023
Precision1
LPL
Lenses, Soft Contact, Daily Wear
24d
Cleared
Dec 27, 2023
TearCare MGX System
ORZ
Eyelid Thermal Pulsation System
254d
Cleared
Dec 21, 2023
CALLISTO eye
NFJ
System, Image Management, Ophthalmic
92d
Cleared
Dec 20, 2023
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear
LPL
Lenses, Soft Contact, Daily Wear
384d
Cleared
Dec 08, 2023
Eagle device
HQF
Laser, Ophthalmic
267d
Cleared
Dec 07, 2023
RM Electrode (RMH 23-01)
HLZ
Electrode, Corneal
129d
Cleared
Dec 05, 2023
Optina-4C (MHRC-C1N)
HKI
Camera, Ophthalmic, Ac-powered
221d
Cleared
Nov 20, 2023
Harmony
NFJ
System, Image Management, Ophthalmic
89d
Cleared
Nov 20, 2023
Zilia Ocular FC (ZIL-10002)
HKI
Camera, Ophthalmic, Ac-powered
259d
Cleared
Nov 17, 2023
Samfilcon B Custom Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
227d
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