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
1105–1128 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR...
K082364 · NFJ
Topcon Corp.
Ophthalmic · 43d
Cleared Sep 29, 2008
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · LPL
CooperVision, Inc.
Ophthalmic · 90d
Cleared Sep 23, 2008
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K081443 · HQD
Menicon Co, Ltd.
Ophthalmic · 124d
Cleared Sep 22, 2008
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
K080803 · HQC
American Optisurgical, Inc.
Ophthalmic · 185d
Cleared Sep 12, 2008
SOLX 790 TITANIUM SAPPHIRE LASER
K081774 · HQF
Solx, Inc.
Ophthalmic · 81d
Cleared Sep 11, 2008
PARKONE
K073508 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 273d
Cleared Sep 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
K081704 · GEX
Lumenis, Inc.
Ophthalmic · 86d
Cleared Sep 11, 2008
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K082393 · LPL
Unilens Corp., USA
Ophthalmic · 23d
Cleared Sep 09, 2008
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
K080776 · HJO
Us Ophthalmic, LLC
Ophthalmic · 174d
Cleared Sep 05, 2008
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
K081455 · MSS
Rayner Surgical, Inc.
Ophthalmic · 105d
Cleared Aug 28, 2008
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
K082132 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Aug 07, 2008
OCULAR RESPONSE ANALYZER
K081756 · HKX
Reichert, Inc.
Ophthalmic · 48d
Cleared Aug 01, 2008
CARRIAZO-PENDULAR MICROKERATOME
K082043 · HNO
Schwind Eye-Tech-Solutions GmbH & Co. KG
Ophthalmic · 14d
Cleared Jul 31, 2008
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
K082031 · HJO
Appasamy Associates
Ophthalmic · 14d
Cleared Jul 23, 2008
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR...
K080512 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 149d
Cleared Jul 18, 2008
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
K080067 · MPA
Iscience Interventional
Ophthalmic · 190d
Cleared Jul 03, 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR...
K073621 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 190d
Cleared Jul 02, 2008
INTEGRE PRO, MODEL L2RY
K081565 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 28d
Cleared Jun 24, 2008
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
K072861 · HJO
Acheve Technology, Inc.
Ophthalmic · 263d
Cleared Jun 20, 2008
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
K072985 · KYB
Duckworth & Kent, Ltd.
Ophthalmic · 241d
Cleared Jun 11, 2008
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
K080180 · HKI
Optical Imaging , Ltd.
Ophthalmic · 139d
Cleared Jun 10, 2008
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 85d
Cleared Jun 03, 2008
FALCK APPLANATION TONOMETER (FAT2)
K071755 · HKY
Falck Medical, Inc.
Ophthalmic · 341d
Cleared May 30, 2008
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS
K081034 · HQD
Synergeyes, Inc.
Ophthalmic · 49d