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
1561–1584 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 06, 2001
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
K011893 · LPL
Contact Color Srl
Ophthalmic · 171d
Cleared Nov 20, 2001
SEREINE EXTRA STRENGTH DAILY CLEANER
K011561 · LPN
Wilsa, Inc.
Ophthalmic · 183d
Cleared Nov 20, 2001
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K013220 · LPL
Poly Vue Technolgies, Inc.
Ophthalmic · 55d
Cleared Nov 20, 2001
CYBERCASES BY BAUSCH & LOMB
K013232 · LRX
Bausch & Lomb, Inc.
Ophthalmic · 54d
Cleared Nov 20, 2001
TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS...
K013467 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 33d
Cleared Nov 20, 2001
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K013469 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 33d
Cleared Nov 19, 2001
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Nov 09, 2001
VANGUARD REPROCESSED PHACOEMULSIFICATION
K012698 · NKX
Vanguard Medical Concepts, Inc.
Ophthalmic · 87d
Cleared Nov 08, 2001
REPROCESSED PHACO TIPS
K012579 · NKX
Sterilmed, Inc.
Ophthalmic · 91d
Cleared Nov 06, 2001
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 201d
Cleared Nov 01, 2001
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
K011796 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 146d
Cleared Oct 26, 2001
CONFOSCAN 2 CONFOCAL MICROSCOPE
K012416 · HJO
Nidek Technologies Srl
Ophthalmic · 88d
Cleared Oct 22, 2001
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
K011392 · MSS
Micra Instruments
Ophthalmic · 168d
Cleared Oct 22, 2001
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
K012821 · HRN
Dutch Ophthalmic USA, Inc.
Ophthalmic · 60d
Cleared Oct 12, 2001
BIOMEDICS UV MULTIFOCAL
K012425 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 74d
Cleared Oct 02, 2001
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
K012435 · NGY
Bausch & Lomb, Inc.
Ophthalmic · 63d
Cleared Sep 26, 2001
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450...
K011877 · HKI
Carl Zeiss Jena GmbH
Ophthalmic · 103d
Cleared Sep 26, 2001
THE INTUITIVE COLORIMETER
K012298 · NFD
Cerium Optical Technologies, Inc.
Ophthalmic · 68d
Cleared Sep 12, 2001
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K011945 · HQD
Polymer Technology Corp.
Ophthalmic · 83d
Cleared Aug 31, 2001
AA-1 SYSTEM
K012530 · HJT
Neurovision, Inc.
Ophthalmic · 25d
Cleared Aug 24, 2001
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT...
K011072 · LPL
Gelflex
Ophthalmic · 137d
Cleared Aug 24, 2001
DISPOSABLE VITRECTOMY LENS
K012096 · HJK
Ocular Instruments, Inc.
Ophthalmic · 50d
Cleared Aug 24, 2001
ULTRACELL ABSORBENT STICK
K012196 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 42d
Cleared Aug 22, 2001
LIGHTLAS 532 PHOTOCOAGULATOR
K010372 · HQF
Lightmed Corp.
Ophthalmic · 196d