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
1009–1032 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 17, 2010
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
K100861 · HLI
Optovue, Inc.
Ophthalmic · 83d
Cleared May 27, 2010
MAIA, MODEL 1
K092187 · HPT
Centervue S.P.A.
Ophthalmic · 310d
Cleared May 21, 2010
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
K100349 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 98d
Cleared CT May 13, 2010
LENSAR LASER SYSTEM
K090633 · OOE
Lensar, Inc.
Ophthalmic · 430d
Cleared May 10, 2010
CENTRAL VISION ANALYZER MODEL 1000
K100095 · HOX
Vimetrics,Llc.
Ophthalmic · 117d
Cleared May 04, 2010
PASCAL STREAMLINE PHOTOCOAGULATOR
K100019 · HQF
Optimedica Corporation
Ophthalmic · 119d
Cleared Apr 27, 2010
POLARIS CONTACT LENS CASE
K093377 · LRX
Reliance Design & Manufacturing Corp.
Ophthalmic · 180d
Cleared Apr 23, 2010
LENSX 550 LASER SYSTEM. MODEL 550
K094052 · OOE
Lensx Lasers, Inc.
Ophthalmic · 113d
Cleared Apr 22, 2010
IVUE, MODEL 100
K091404 · OBO
Optovue, Inc.
Ophthalmic · 345d
Cleared Apr 02, 2010
ENHANCED ULTRA VIT PROBE
K093305 · MLZ
Alcon Research, Ltd.
Ophthalmic · 162d
Cleared Mar 19, 2010
SLIT LAMP BO 900, BQ 900, BP900
K100202 · HJO
Haag-Streit AG
Ophthalmic · 53d
Cleared Mar 18, 2010
DIGITAL RETINAL CAMERA CX-1
K092565 · HKI
Canon Components, Inc.
Ophthalmic · 210d
Cleared Mar 12, 2010
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K093213 · HPT
Carl Zeiss Meditec, Inc.
Ophthalmic · 150d
Cleared Mar 11, 2010
SAVIEW 58 UV
K092852 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 176d
Cleared Mar 09, 2010
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K082855 · MRC
Menicon Co, Ltd.
Ophthalmic · 526d
Cleared Mar 09, 2010
PSL CLASSIC SLIT LAMP
K100500 · HJO
Keeler Instruments, Inc.
Ophthalmic · 15d
Cleared Mar 04, 2010
AQUALASE CAPSULE WASH TIP
K093210 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 142d
Cleared Feb 12, 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207 · HKI
Topcon Corp.
Ophthalmic · 18d
Cleared Jan 28, 2010
ATLANTIS SLIT LAMP
K093021 · HJO
Us Opthalmic, LLC
Ophthalmic · 121d
Cleared Jan 19, 2010
KEELER APPLANATION TONOMETER
K093445 · HKY
Keeler, Ltd.
Ophthalmic · 90d
Cleared Jan 05, 2010
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · LPL
CooperVision, Inc.
Ophthalmic · 244d
Cleared CT Dec 23, 2009
FORESEE HOME
K091579 · HPT
Notal Vision , Ltd.
Ophthalmic · 204d
Cleared Dec 18, 2009
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS,...
K090806 · LPL
Safilens, S.R.L.
Ophthalmic · 268d
Cleared Dec 18, 2009
LED LAMP OR OTHER
K092883 · HJO
Intravista Medical Systems, Inc.
Ophthalmic · 91d