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
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
Cleared
Oct 11, 2022
ECHO Photocoagulator
HQF
Laser, Ophthalmic
83d
Cleared
Oct 06, 2022
iCare IC200
HKY
Tonometer, Manual
197d
Cleared
Oct 05, 2022
Cornisol
LYX
Media, Corneal Storage
110d
Cleared
Oct 04, 2022
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
132d
Cleared
Sep 29, 2022
CureSight-CS100
QQU
Digital Therapy Device For Amblyopia
140d
Cleared
Sep 15, 2022
AIR OPTIX COLORS
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Sep 09, 2022
MICOR Lens Fragmentation System
HQC
Unit, Phacofragmentation
261d
Cleared
Sep 08, 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
233d
Cleared
Sep 07, 2022
EyeCTester
QTW
Digital Amsler Grid
637d
Cleared
Sep 02, 2022
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
LPL
Lenses, Soft Contact, Daily Wear
256d
Cleared
Aug 29, 2022
Non-Mydriatic Retinal Camera NW500
HKI
Camera, Ophthalmic, Ac-powered
136d
Cleared
Aug 24, 2022
miCOR System Lens Fragmentation System
HQC
Unit, Phacofragmentation
29d
Cleared
Aug 15, 2022
FORUM
NFJ
System, Image Management, Ophthalmic
284d
Cleared
Aug 12, 2022
Visibly Digital Acuity Product
QTO
Digital Visual Acuity Test
213d
Cleared
Aug 10, 2022
UniVit HE, UniVit UHS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
344d
Cleared
Aug 05, 2022
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
LPL
Lenses, Soft Contact, Daily Wear
212d
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