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
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
Cleared
Jan 12, 2015
DacryoCATH
OKS
Lacrimal Stents And Intubation Sets
97d
Cleared
Dec 18, 2014
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
MSS
Folders And Injectors, Intraocular Lens (iol)
30d
Cleared
Dec 16, 2014
Sensor Medical Family of Vitrectomy Lenses and Products
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
85d
Cleared
Dec 16, 2014
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily
LPL
Lenses, Soft Contact, Daily Wear
54d
Cleared
Dec 12, 2014
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
LPL
Lenses, Soft Contact, Daily Wear
108d
Cleared
Dec 05, 2014
Viscoelastic Injector
MRH
Pump, Infusion, Ophthalmic
28d
Cleared
Dec 02, 2014
STOPLOSS JONES TUBE
OKS
Lacrimal Stents And Intubation Sets
300d
Cleared
Nov 19, 2014
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
HQD
Lens, Contact (other Material) - Daily
72d
Cleared
Nov 18, 2014
RESCAN 700, CALLISTO EYE
OBO
Tomography, Optical Coherence
133d
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