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
2883 Ophthalmic devices
Cleared
Aug 10, 2015
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
60d
Cleared
Aug 06, 2015
Cornea Cold
LYX
Media, Corneal Storage
108d
Cleared
Jul 14, 2015
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
HQF
Laser, Ophthalmic
321d
Cleared
Jul 10, 2015
IOLMaster700
HJO
Biomicroscope, Slit-lamp, Ac-powered
238d
Cleared
Jul 10, 2015
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
LPL
Lenses, Soft Contact, Daily Wear
123d
Cleared
Jun 30, 2015
COMPASS
MYC
Ophthalmoscope, Laser, Scanning
141d
Cleared
Jun 25, 2015
Ophthalmed Bending Laser Probes
HQF
Laser, Ophthalmic
268d
Cleared
Jun 24, 2015
VICTUS Femtosecond Laser Platform
OOE
Ophthalmic Femtosecond Laser
54d
Cleared
Jun 22, 2015
VISCO SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
396d
Not Cleared
Jun 18, 2015
BRAINPORT V100 DEVICE
PIC
Oral Electronic Vision Aid
680d
Cleared
Jun 15, 2015
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
MVN
Lens, Contact, (disposable)
96d
Cleared
Jun 01, 2015
VX120 Ophthalmic Diagnostic Device
HKX
Tonometer, Ac-powered
217d
Cleared
May 29, 2015
SP-1PSpecular Microscope
NQE
Microscope, Specular
274d
Cleared
May 22, 2015
Bausch + Lomb Injector System
MSS
Folders And Injectors, Intraocular Lens (iol)
28d
Cleared
May 21, 2015
Retina Workplace
NFJ
System, Image Management, Ophthalmic
87d
Cleared
May 18, 2015
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
HLJ
Ophthalmoscope, Battery-powered
256d
Cleared
May 07, 2015
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
LRX
Case, Contact Lens
226d
Cleared
May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
MSS
Folders And Injectors, Intraocular Lens (iol)
156d
Cleared
Apr 30, 2015
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear
LPL
Lenses, Soft Contact, Daily Wear
212d
Cleared
Apr 30, 2015
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
71d
Cleared
Apr 29, 2015
iCase Contact Lens Case
LRX
Case, Contact Lens
156d
Cleared
Apr 23, 2015
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
160d
Cleared
Apr 15, 2015
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)
LPL
Lenses, Soft Contact, Daily Wear
68d
Cleared
Apr 09, 2015
LIOLI IOL DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
254d
Cleared
Mar 20, 2015
LENSAR Laser System - fs 3D
OOE
Ophthalmic Femtosecond Laser
151d
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