FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
697–720 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 05, 2014
Viscoelastic Injector
K143205 · MRH
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Dec 02, 2014
STOPLOSS JONES TUBE
K140290 · OKS
Ljt Surgical, Ltd.
Ophthalmic · 300d
Cleared Nov 19, 2014
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea...
K142510 · HQD
Synergeyes, Inc.
Ophthalmic · 72d
Cleared Nov 18, 2014
RESCAN 700, CALLISTO EYE
K141844 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 133d
Cleared Nov 13, 2014
VERAPLUG
K140352 · LZU
Krishna Imports Inc Dba Stephens...
Ophthalmic · 274d
Cleared Nov 12, 2014
EIDON
K142047 · MYC
Centervue S.P.A.
Ophthalmic · 107d
Cleared Oct 30, 2014
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
K142851 · LPL
Unilens Corp., USA
Ophthalmic · 30d
Cleared Oct 23, 2014
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
K141325 · HKI
Topcon Corp.
Ophthalmic · 156d
Cleared Oct 17, 2014
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR...
K141917 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 94d
Cleared Oct 15, 2014
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K140025 · LPL
Pegavision Corporation
Ophthalmic · 282d
Cleared Oct 15, 2014
XCEL 455 SLIT LAMP
K141954 · HJO
Reichert, Inc.
Ophthalmic · 89d
Cleared Oct 07, 2014
VASSEN COLOR
K141699 · LPL
Vassen Co., Ltd.
Ophthalmic · 105d
Cleared Oct 07, 2014
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
K142275 · LPL
Neo Vision Co., Ltd.
Ophthalmic · 53d
Cleared Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
K141297 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 137d
Cleared Sep 30, 2014
WAVELIGHT FS200 LASER SYSTEM
K141476 · OOE
Alcon Research, Ltd. Dba Alcon...
Ophthalmic · 118d
Cleared Sep 18, 2014
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
K141670 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 87d
Cleared Sep 17, 2014
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
K141481 · HKI
Topcon Corporation
Ophthalmic · 105d
Cleared Sep 17, 2014
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
K141638 · HLI
Propper Manufacturing Co., Inc.
Ophthalmic · 90d
Cleared Sep 17, 2014
D-KAT Z-YPE
K142179 · HKY
Keeler, Ltd.
Ophthalmic · 40d
Cleared Sep 15, 2014
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES,...
K140362 · HQF
Katalyst Surgical, LLC
Ophthalmic · 215d
Cleared Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K141079 · OOE
Optimedica Corporation
Ophthalmic · 139d
Cleared Sep 10, 2014
CONTACT LENS CASE
K140488 · LRX
Maca Plastics, Inc.
Ophthalmic · 195d
Cleared Sep 10, 2014
EyeSuite Imaging
K142423 · NFJ
Haag-Streit AG
Ophthalmic · 13d
Cleared Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
K141068 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 138d