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
769–792 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 14, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K132534 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 185d
Cleared Feb 14, 2014
STELLARIS VISION ENHANCEMENT SYSTEM
K133242 · HQC
Bausch & Lomb
Ophthalmic · 116d
Cleared Feb 12, 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
K130930 · LRX
Ningbo Lishunda Electronics Co., Ltd.
Ophthalmic · 314d
Cleared Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
K133476 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared CT Jan 29, 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
K133176 · LPL
Ciba Vision Corporation
Ophthalmic · 104d
Cleared Jan 09, 2014
BAUSCH & LOMB INJECTOR SYSTEM
K131958 · MSS
Bausch & Lomb
Ophthalmic · 196d
Cleared Jan 03, 2014
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
K133146 · MSS
Bausch & Lomb
Ophthalmic · 78d
Cleared Dec 27, 2013
EASY-LOAD LENS DELIVERY SYSTEM
K132481 · MSS
Bausch & Lomb
Ophthalmic · 141d
Cleared Dec 23, 2013
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K131787 · HRN
Keeler, Ltd.
Ophthalmic · 188d
Cleared Dec 23, 2013
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K132854 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 102d
Cleared Dec 23, 2013
LIPIFLOW THERMAL PULSATION SYSTEM
K133127 · ORZ
Tearscience, Inc.
Ophthalmic · 84d
Cleared Dec 23, 2013
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · LPL
CooperVision, Inc.
Ophthalmic · 27d
Cleared Dec 20, 2013
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS
K132715 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 112d
Cleared Dec 20, 2013
OCULAR FORCE GAUGE
K132917 · HKY
Ocular Therapeutix, Inc.
Ophthalmic · 94d
Cleared Dec 18, 2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
K132186 · HKI
Optomed OY
Ophthalmic · 156d
Cleared Dec 17, 2013
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2...
K133079 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 78d
Cleared Dec 04, 2013
SELF-RETAINING BICANALICULUS INTUBATON SET II
K130375 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 293d
Cleared Dec 04, 2013
HEINE BETA 200(R) OPHTHALMOSCOPE
K131961 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 160d
Cleared Nov 27, 2013
SPECULAR MICROSCOPE CEM-530
K130565 · NQE
Nidek Co., Ltd.
Ophthalmic · 268d
Cleared Nov 14, 2013
PEREGRINE CURVED ILLUMINATING LASER PROBE
K132614 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Nov 01, 2013
SCANNING LASERLINK
K130195 · HQF
Lumenis, Inc.
Ophthalmic · 277d
Cleared Oct 30, 2013
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
K131719 · HLJ
Medical Devices (Pvt) , Ltd.
Ophthalmic · 140d
Cleared Oct 30, 2013
SUNTOUCH EYE SPEAR
K132796 · HOZ
Huizhou Foryou Medical Devices Co., Ltd.
Ophthalmic · 54d
Cleared Oct 29, 2013
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
K130117 · HOZ
Network Medical Products, Ltd.
Ophthalmic · 286d