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
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
Cleared
Nov 13, 2014
VERAPLUG
LZU
Plug, Punctum
274d
Cleared
Nov 12, 2014
EIDON
MYC
Ophthalmoscope, Laser, Scanning
107d
Cleared
Oct 30, 2014
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Oct 23, 2014
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
156d
Cleared
Oct 17, 2014
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
94d
Cleared
Oct 15, 2014
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
282d
Cleared
Oct 15, 2014
XCEL 455 SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
89d
Cleared
Oct 07, 2014
VASSEN COLOR
LPL
Lenses, Soft Contact, Daily Wear
105d
Cleared
Oct 07, 2014
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
NFJ
System, Image Management, Ophthalmic
137d
Cleared
Sep 30, 2014
WAVELIGHT FS200 LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
118d
Cleared
Sep 18, 2014
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
LPL
Lenses, Soft Contact, Daily Wear
87d
Cleared
Sep 17, 2014
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
105d
Cleared
Sep 17, 2014
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
HLI
Ophthalmoscope, Ac-powered
90d
Cleared
Sep 17, 2014
D-KAT Z-YPE
HKY
Tonometer, Manual
40d
Cleared
Sep 15, 2014
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
HQF
Laser, Ophthalmic
215d
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