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 15, 2016
SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co
HQD
Lens, Contact (other Material) - Daily
327d
Cleared
Nov 04, 2016
LipiFlow Thermal Pulsation System
ORZ
Eyelid Thermal Pulsation System
172d
Cleared
Nov 03, 2016
Nunchaku
OKS
Lacrimal Stents And Intubation Sets
170d
Cleared
Oct 26, 2016
PLEX Elite 9000 SS-OCT
OBO
Tomography, Optical Coherence
182d
Cleared
Oct 24, 2016
Visco (olifilcon A) soft contact lens
LPL
Lenses, Soft Contact, Daily Wear
266d
Cleared
Oct 24, 2016
Ahmed Glaucoma Valve
KYF
Implant, Eye Valve
90d
Cleared
Oct 21, 2016
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Oct 19, 2016
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
LPN
Accessories, Soft Lens Products
30d
Cleared
Oct 13, 2016
AIR OPTIX COLORS
LPL
Lenses, Soft Contact, Daily Wear
27d
Cleared
Oct 12, 2016
Toricolors (hioxifilcon D) Soft Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
90d
Cleared
Oct 05, 2016
R:GEN Laser System
HQF
Laser, Ophthalmic
280d
Cleared
Oct 05, 2016
ALADDIN HW3.0
HJO
Biomicroscope, Slit-lamp, Ac-powered
243d
Cleared
Oct 04, 2016
Eyenez Ophthalmic Camera
HKI
Camera, Ophthalmic, Ac-powered
104d
Cleared
Sep 20, 2016
Catalys Precision Laser System
OOE
Ophthalmic Femtosecond Laser
117d
Cleared
Sep 15, 2016
Eusol-C
LYX
Media, Corneal Storage
56d
Cleared
Aug 26, 2016
EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
LPL
Lenses, Soft Contact, Daily Wear
127d
Cleared
Aug 22, 2016
ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
LPL
Lenses, Soft Contact, Daily Wear
125d
Cleared
Aug 11, 2016
SACCADOMETER PLUS, SACCADOMETER ADVANCED
HLL
Monitor, Eye Movement
316d
Cleared
Aug 11, 2016
LensGiene Sterile Saline Solution
LPN
Accessories, Soft Lens Products
59d
Cleared
Aug 10, 2016
Hidrocor, Hidrocharme, and Natural Colors
LPL
Lenses, Soft Contact, Daily Wear
173d
Cleared
Aug 10, 2016
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
HQD
Lens, Contact (other Material) - Daily
113d
Cleared
Aug 01, 2016
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens
HQD
Lens, Contact (other Material) - Daily
119d
Cleared
Jul 28, 2016
3D OCT-1 Maestro
OBO
Tomography, Optical Coherence
57d
Cleared
Jul 25, 2016
BostonSight PD Prosthetic Device
HQD
Lens, Contact (other Material) - Daily
60d
Cleared
Jul 13, 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
112d
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