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
2881 Ophthalmic devices
Cleared
Feb 08, 2017
OptosAdvance 4.0 Software
NFJ
System, Image Management, Ophthalmic
201d
Cleared
Feb 03, 2017
LenSx Laser System
OOE
Ophthalmic Femtosecond Laser
46d
Cleared
Jan 23, 2017
D.O.R.C. Disposable Cryo Probe
HRN
Unit, Cryophthalmic, Ac-powered
328d
Cleared
Jan 18, 2017
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
58d
Cleared
Jan 04, 2017
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
LPL
Lenses, Soft Contact, Daily Wear
149d
Cleared
Dec 19, 2016
Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
178d
Cleared
Dec 09, 2016
Slit Lamp SL-D301
HJO
Biomicroscope, Slit-lamp, Ac-powered
144d
Cleared
Dec 09, 2016
EnFocus 2300, EnFocus 4400
OBO
Tomography, Optical Coherence
67d
Cleared
Dec 09, 2016
Contact Lens Case
LRX
Case, Contact Lens
57d
Cleared
Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
141d
Cleared
Nov 30, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
LPL
Lenses, Soft Contact, Daily Wear
195d
Cleared
Nov 29, 2016
Lenstec LC Injection system
MSS
Folders And Injectors, Intraocular Lens (iol)
153d
Cleared
Nov 25, 2016
NNR06 Multi-Purpose Solution
LPN
Accessories, Soft Lens Products
147d
Cleared
Nov 21, 2016
XEN Glaucoma Treatment System
KYF
Implant, Eye Valve
179d
Cleared
Nov 18, 2016
LacriPro Punctum Plug
LZU
Plug, Punctum
155d
Cleared
Nov 16, 2016
LenSX Laser System
OOE
Ophthalmic Femtosecond Laser
191d
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
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