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 02, 2018
Afina
NFJ
System, Image Management, Ophthalmic
148d
Cleared
Nov 01, 2018
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
49d
Cleared
Oct 25, 2018
Endocular Viewing Lenses and Silicone Ring
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
303d
Cleared
Oct 24, 2018
Retina Workplace
NFJ
System, Image Management, Ophthalmic
58d
Cleared
Oct 22, 2018
Nutrifill
MRC
Products, Contact Lens Care, Rigid Gas Permeable
130d
Cleared
Oct 18, 2018
Spectralis HRA+OCT and variants with High Magnification Module
OBO
Tomography, Optical Coherence
30d
Cleared
Oct 12, 2018
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Sep 28, 2018
RightEye Vision System
GWN
Nystagmograph
87d
Cleared
Sep 28, 2018
Harmony
NFJ
System, Image Management, Ophthalmic
28d
Cleared
Sep 19, 2018
Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
121d
Cleared
Sep 13, 2018
Spectralis HRA+OCT and variants with OCT Angiography Module
OBO
Tomography, Optical Coherence
87d
Cleared
Sep 07, 2018
RetCam 3
HKI
Camera, Ophthalmic, Ac-powered
17d
Cleared
Sep 06, 2018
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
85d
Cleared
Sep 05, 2018
Iridex TruFocus LIO Premiere
GEX
Powered Laser Surgical Instrument
72d
Cleared
Aug 30, 2018
Spectralis HRA + OCT and variants
OBO
Tomography, Optical Coherence
276d
Cleared
Aug 24, 2018
IOLMaster 700
HJO
Biomicroscope, Slit-lamp, Ac-powered
256d
Cleared
Aug 10, 2018
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
MRC
Products, Contact Lens Care, Rigid Gas Permeable
51d
Cleared
Aug 09, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
69d
Cleared
Aug 03, 2018
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
LPL
Lenses, Soft Contact, Daily Wear
29d
Cleared
Jul 27, 2018
RetiCapture
HKI
Camera, Ophthalmic, Ac-powered
260d
Cleared
Jul 26, 2018
RxSight Insertion Device
MSS
Folders And Injectors, Intraocular Lens (iol)
58d
Cleared
Jul 26, 2018
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K
HQD
Lens, Contact (other Material) - Daily
41d
Cleared
Jul 19, 2018
Image Filing Software NAVIS-EX
NFJ
System, Image Management, Ophthalmic
59d
Cleared
Jul 16, 2018
EIDON FA
MYC
Ophthalmoscope, Laser, Scanning
139d
Cleared
Jul 16, 2018
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
NFJ
System, Image Management, Ophthalmic
90d
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