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
769–792 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Oct 22, 2013
VISCOELASTIC INJECTOR
K132494 · MRH
Sight Sciences, Inc.
Ophthalmic · 74d
Cleared Oct 18, 2013
LENSTEC LC INJECTION SYSTEM
K122848 · MSS
Lenstec, Inc.
Ophthalmic · 395d
Cleared Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
K132438 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 73d
Cleared Oct 09, 2013
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
K131207 · HQF
Surgical Instrument Engineering AG
Ophthalmic · 163d
Cleared Oct 09, 2013
SYNERGY ODM
K132667 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 43d
Cleared Sep 26, 2013
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K124043 · HQF
Lightmed Corp.
Ophthalmic · 272d
Cleared Sep 17, 2013
CRYSTALSERT DELIVERY SYSTEM
K132593 · MSS
Bausch & Lomb
Ophthalmic · 29d
Cleared Sep 11, 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT...
K131208 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 135d
Cleared Sep 09, 2013
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
K132216 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 54d