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
913–936 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND...
K111877 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 207d
Cleared Jan 19, 2012
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and...
K111157 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 269d
Cleared Dec 29, 2011
TRIMOTION INJECTOR
K102999 · OTZ
Kaneka Corp.
Ophthalmic · 447d
Cleared Dec 21, 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
K111446 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 211d
Cleared Dec 21, 2011
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC,...
K112302 · LPL
CooperVision, Inc.
Ophthalmic · 132d
Cleared Dec 21, 2011
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K113479 · OOE
Optimedica Corporation
Ophthalmic · 28d
Cleared Dec 19, 2011
LIPIFLOW THERMAL PULSATION SYSTEM
K112704 · ORZ
Tearscience, Inc.
Ophthalmic · 94d
Cleared Dec 08, 2011
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
K112093 · HRN
Keeler Instruments, Inc.
Ophthalmic · 139d
Cleared Dec 05, 2011
EYE CARE CURE CONTACT LENS CASE
K112832 · LRX
Eye Care and Cure
Ophthalmic · 67d
Cleared Dec 02, 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
K113245 · LPL
CooperVision, Inc.
Ophthalmic · 30d
Cleared Dec 02, 2011
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
K113267 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Nov 30, 2011
NON-CONTACT TEAR FILM THERMOGRAGH
K111771 · HKI
United Integrated Services Co., Ltd.
Ophthalmic · 160d
Cleared Nov 22, 2011
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
K110427 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 281d
Cleared Nov 21, 2011
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
K112425 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 90d
Cleared Nov 08, 2011
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
K111267 · LPL
Abbconcise Optical Group, LLC
Ophthalmic · 188d
Cleared Nov 08, 2011
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
K113129 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 15d
Cleared Nov 07, 2011
LAMINAR FLOW PHACO TIPS
K111882 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 129d
Cleared Nov 03, 2011
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K103547 · HQF
Lightmed Corp.
Ophthalmic · 336d
Cleared Nov 03, 2011
OPTO MITRA YELLOW LASER
K111643 · HQF
Opto Electronica SA
Ophthalmic · 143d
Cleared Nov 02, 2011
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
K110554 · HPZ
Ceramisys, Ltd.
Ophthalmic · 247d
Cleared Nov 02, 2011
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT...
K111345 · LPL
The See Clear Company, Inc.
Ophthalmic · 173d
Cleared Nov 01, 2011
EYE-CEPT STERILE SALINE SOLUTION
K110221 · LPN
Optics Laboratory, Inc.
Ophthalmic · 280d
Cleared Oct 28, 2011
EASYSCAN MODEL 1.2
K111988 · MYC
I-Optics BV
Ophthalmic · 107d
Cleared Oct 25, 2011
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 88d