Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
1033–1056 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 11, 2009
LENSX 550 LASER SYSTEM
K092647 · OOE
Lensx Lasers, Inc.
Ophthalmic · 106d
Cleared Dec 04, 2009
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
K091507 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 197d
Cleared Dec 03, 2009
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
K093639 · HJO
Huvitz Co., Ltd.
Ophthalmic · 9d
Cleared Nov 25, 2009
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
K090326 · HKI
Clarity Medical Systems
Ophthalmic · 289d
Cleared Nov 25, 2009
GDXPRO
K093521 · MYC
Carl Zeiss Meditec, Inc.
Ophthalmic · 12d
Cleared CT Nov 18, 2009
BPZ02 MULTIPURPOSE SOLUTION
K083757 · LYL
Bausch & Lomb, Inc.
Ophthalmic · 336d
Cleared Nov 17, 2009
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K092374 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 104d
Cleared Oct 27, 2009
NAVILAS LASER SYSTEM
K091064 · HQF
Od-Os GmbH
Ophthalmic · 196d
Cleared Oct 27, 2009
FLUID ISOLATION DEVICE
K091915 · HQC
Lenstec, Inc.
Ophthalmic · 119d
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