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
1033–1056 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 23, 2009
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K091240 · HOZ
Alphamed, Inc.
Ophthalmic · 179d
Cleared Oct 23, 2009
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K091935 · HKI
Tearscience, Inc.
Ophthalmic · 115d
Cleared Oct 20, 2009
LENSTAR, MODEL LS900
K082891 · HJO
Haag-Streit AG
Ophthalmic · 385d
Cleared Oct 20, 2009
ALCON ULTRACHOPPER
K091777 · HQC
Alcon Research, Ltd.
Ophthalmic · 125d
Cleared Oct 01, 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
K092056 · HKI
Optomed OY
Ophthalmic · 86d
Cleared Sep 28, 2009
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
K091981 · HQF
Lightmed Corp.
Ophthalmic · 89d
Cleared Sep 25, 2009
PASCAL STREAMLINE PHOTOCOAGULATOR
K092621 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 30d
Cleared Sep 18, 2009
LIGHTLAS MODEL 532
K091534 · HQF
Lightmed Corp.
Ophthalmic · 115d
Cleared Sep 03, 2009
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
K083288 · LPL
Innova Vision, Inc.
Ophthalmic · 300d
Cleared Sep 02, 2009
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
K092470 · OBO
Topcon Corp.
Ophthalmic · 21d
Cleared Sep 01, 2009
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED...
K083428 · HQP
Fiab Spa
Ophthalmic · 286d
Cleared Aug 14, 2009
LENSX 550 LASER SYSTEM
K082947 · OOE
Lensx Lasers, Inc.
Ophthalmic · 316d
Cleared Aug 13, 2009
LIGHTLAS SELECTOR
K090774 · HQF
Lightmed Corp.
Ophthalmic · 143d
Cleared Aug 10, 2009
GDX VCC WITH ECC SOFTWARE
K082016 · MYC
Carl Zeiss Meditec, Inc.
Ophthalmic · 391d
Cleared Aug 07, 2009
KOWA, FM-600, MODEL LSS50
K091039 · MYC
Kowa Co. , Ltd.
Ophthalmic · 116d
Cleared Aug 07, 2009
KOWAGENESIS-DF
K091098 · HKI
Kowa Co. , Ltd.
Ophthalmic · 113d
Cleared Jul 28, 2009
NAVIJECT SUB2-1P, MODEL: LP604430
K092023 · MSS
Medicel AG
Ophthalmic · 22d
Cleared Jul 27, 2009
ACCUPEN
K083377 · HKX
Accutome Ultrasound, Inc.
Ophthalmic · 255d
Cleared Jul 09, 2009
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
K082871 · MSS
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 283d
Cleared Jul 09, 2009
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · LPN
Allergan, Inc.
Ophthalmic · 199d
Cleared Jul 02, 2009
KOWA VX-10 A
K091683 · HKI
Kowa Co. , Ltd.
Ophthalmic · 22d
Cleared Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
K090115 · HKI
Topcon Corp.
Ophthalmic · 160d
Cleared Jun 16, 2009
STATIC VESSEL ANALYZER
K082196 · HKI
Imedos GmbH
Ophthalmic · 316d
Cleared Jun 16, 2009
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K082879 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d