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
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
Cleared
Nov 21, 2022
Kowa SL-19
HJO
Biomicroscope, Slit-lamp, Ac-powered
108d
Cleared
Nov 10, 2022
AEYE-DS
PIB
Diabetic Retinopathy Detection Device
199d
Cleared
Nov 09, 2022
SOLIX
OBO
Tomography, Optical Coherence
111d
Cleared
Nov 09, 2022
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
HQF
Laser, Ophthalmic
37d
Cleared
Nov 04, 2022
Luminopia One
QQU
Digital Therapy Device For Amblyopia
149d
Cleared
Nov 03, 2022
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
HQB
Photocoagulator And Accessories
276d
Cleared
Nov 02, 2022
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
HQF
Laser, Ophthalmic
86d
Cleared
Oct 31, 2022
Excelsior
NFJ
System, Image Management, Ophthalmic
214d
Cleared
Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
LPN
Accessories, Soft Lens Products
163d
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