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
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
Cleared
Mar 20, 2015
myVision Track Model 005
HOQ
Grid, Amsler
130d
Cleared
Mar 13, 2015
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
HQC
Unit, Phacofragmentation
163d
Cleared
Mar 12, 2015
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
LPL
Lenses, Soft Contact, Daily Wear
168d
Cleared
Mar 04, 2015
OCT-Camera
HLI
Ophthalmoscope, Ac-powered
145d
Cleared
Feb 27, 2015
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
NFJ
System, Image Management, Ophthalmic
226d
Cleared
Feb 27, 2015
LIGHTMED TRUSCAN 577
HQF
Laser, Ophthalmic
204d
Cleared
Feb 24, 2015
Synergetics PHOTON EX
MPA
Endoilluminator
116d
Cleared
Feb 20, 2015
FIBERION OPHTHALMIC ENDOLASER PROBE
HQF
Laser, Ophthalmic
512d
Cleared
Feb 20, 2015
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
LPL
Lenses, Soft Contact, Daily Wear
81d
Cleared
Feb 13, 2015
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Jan 29, 2015
HEINE SIGMA 250 & HEINE SIGMA 250 M2
HLJ
Ophthalmoscope, Battery-powered
121d
Cleared
Jan 26, 2015
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
LPN
Accessories, Soft Lens Products
161d
Cleared
Jan 16, 2015
VICTUS FEMTOSECOND LASER PLATFORM
OOE
Ophthalmic Femtosecond Laser
234d
Cleared
Jan 16, 2015
P200DTx
MYC
Ophthalmoscope, Laser, Scanning
105d
Cleared
Jan 16, 2015
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
MVN
Lens, Contact, (disposable)
72d
Cleared
Jan 12, 2015
Intelliwave4
LPL
Lenses, Soft Contact, Daily Wear
117d
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