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
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
Cleared
Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
139d
Cleared
Sep 10, 2014
CONTACT LENS CASE
LRX
Case, Contact Lens
195d
Cleared
Sep 10, 2014
EyeSuite Imaging
NFJ
System, Image Management, Ophthalmic
13d
Cleared
Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
HJO
Biomicroscope, Slit-lamp, Ac-powered
138d
Cleared
Aug 26, 2014
SLIT LAMP SL-D701
HJO
Biomicroscope, Slit-lamp, Ac-powered
270d
Cleared
Aug 22, 2014
CONSTELLATION VISION SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
120d
Cleared
Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
HQF
Laser, Ophthalmic
285d
Cleared
Aug 12, 2014
CATARHEX 3
HQC
Unit, Phacofragmentation
265d
Cleared
Jul 18, 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
63d
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