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
793–816 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 CT 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
Cleared Aug 30, 2013
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
K130931 · LPL
Jiangsu Horien Contact Lens Co., Ltd.
Ophthalmic · 148d
Cleared Aug 30, 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · LPL
CooperVision, Inc.
Ophthalmic · 108d
Cleared Aug 30, 2013
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT...
K132146 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 50d
Cleared Aug 06, 2013
MENICON NECT CONTACT LENS CASE
K131875 · LRX
Foresight Regulatory Strategies
Ophthalmic · 43d
Cleared CT Aug 05, 2013
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
K130342 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 175d
Cleared Aug 02, 2013
SOLUTIS
K130933 · HQF
Quantel Medical
Ophthalmic · 120d
Cleared Jul 29, 2013
OPHTACATH KIT
K123831 · OKS
France Chirurgae Instrumentation
Ophthalmic · 229d
Cleared Jul 26, 2013
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE...
K130331 · MVN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
K130648 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 134d
Cleared Jul 03, 2013
IFUSION
K130656 · HKI
Optovue, Inc.
Ophthalmic · 113d
Cleared Jul 03, 2013
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
K130805 · MRC
Menicon Co, Ltd.
Ophthalmic · 100d
Cleared Jul 01, 2013
ELLEX 2RT
K122202 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 341d
Cleared Jun 27, 2013
KEELER SLIT LAMP H-SERIES
K131589 · HJO
Keeler, Ltd.
Ophthalmic · 27d
Cleared Jun 26, 2013
23GA CURVED ILLUMINATING LASER PROBE
K122997 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 272d
Cleared Jun 17, 2013
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II...
K123431 · LPL
Dreamcon Co., Ltd.
Ophthalmic · 222d