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
Jun 12, 2023
RxSight Insertion Device
MSS
Folders And Injectors, Intraocular Lens (iol)
24d
Cleared
Jun 02, 2023
CorNeat EverPatch
QWU
Prosthesis, Eyelid Spacer/graft, Polymer
245d
Cleared
May 31, 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
LPL
Lenses, Soft Contact, Daily Wear
250d
Cleared
May 12, 2023
Ahmed® Glaucoma Valve Model FP7
KYF
Implant, Eye Valve
37d
Cleared
May 12, 2023
Ahmed® Glaucoma Valve Model FP8
KYF
Implant, Eye Valve
29d
Cleared
May 09, 2023
Retitrack
HLL
Monitor, Eye Movement
265d
Cleared
May 05, 2023
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
HQD
Lens, Contact (other Material) - Daily
322d
Cleared
Apr 20, 2023
Precision1, Precision1 for Astigmatism
LPL
Lenses, Soft Contact, Daily Wear
29d
Cleared
Apr 14, 2023
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
OOE
Ophthalmic Femtosecond Laser
136d
Cleared
Apr 13, 2023
CIRRUS HD-OCT
OBO
Tomography, Optical Coherence
262d
Cleared
Apr 12, 2023
Catalys™ Precision Laser System
OOE
Ophthalmic Femtosecond Laser
111d
Cleared
Apr 11, 2023
ZeptoLink IOL Positioning System
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
117d
Cleared
Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX
OBO
Tomography, Optical Coherence
328d
Cleared
Mar 30, 2023
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
MPA
Endoilluminator
275d
Cleared
Mar 15, 2023
iExaminer System with Panoptic Plus
HKI
Camera, Ophthalmic, Ac-powered
128d
Cleared
Mar 13, 2023
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
167d
Cleared
Mar 08, 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
LPL
Lenses, Soft Contact, Daily Wear
370d
Cleared
Feb 23, 2023
Iridex 532 Laser
HQF
Laser, Ophthalmic
27d
Cleared
Feb 22, 2023
Eyer Retinal Camera NM-STD
HKI
Camera, Ophthalmic, Ac-powered
292d
Cleared
Dec 27, 2022
R:GEN
HQF
Laser, Ophthalmic
267d
Cleared
Dec 23, 2022
Visant Medical Canalicular Plug
LZU
Plug, Punctum
155d
Cleared
Dec 07, 2022
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
HQD
Lens, Contact (other Material) - Daily
29d
Cleared
Dec 06, 2022
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
LPN
Accessories, Soft Lens Products
106d
Cleared
Nov 22, 2022
E3 and Profile
GWE
Stimulator, Photic, Evoked Response
186d
Cleared
Nov 21, 2022
Vision Monitor- MonCvONE
GWE
Stimulator, Photic, Evoked Response
432d
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