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
May 17, 2024
Kahook Dual Blade Glide (KDB Glide)
QUQ
Knife, Intraocular Pressure Lowering
781d
Cleared
May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
HKI
Camera, Ophthalmic, Ac-powered
28d
Not Cleared
May 15, 2024
Notal Vision Home Optical Coherence Tomography (OCT) System
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (oct) Imaging Device
343d
Cleared
May 09, 2024
P200TE (A10700)
OBO
Tomography, Optical Coherence
182d
Cleared
May 08, 2024
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
251d
Cleared
May 01, 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
HKY
Tonometer, Manual
182d
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
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