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
1561–1584 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Aug 13, 2001
OSMED TISSUE EXPANDER
K010852 · NFM
Iop, Inc.
Ophthalmic · 145d
Cleared Aug 01, 2001
THE ALBERTA LENS SM2, SULFOCON B
K010454 · HQD
Progressive Optical Research , Ltd.
Ophthalmic · 167d
Cleared Jul 27, 2001
HYDRO2, HS-75
K011914 · HQD
Innovision, Inc.
Ophthalmic · 38d
Cleared Jul 25, 2001
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED...
K011718 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 51d
Cleared Jul 17, 2001
TORIC LITE LENS
K011256 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 84d
Cleared Jul 17, 2001
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
K011456 · MRC
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 67d
Cleared Jul 09, 2001
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT...
K001962 · LPL
Bescon Co., Ltd.
Ophthalmic · 377d
Cleared Jul 09, 2001
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS...
K002099 · LPL
Bescon Co., Ltd.
Ophthalmic · 363d
Cleared Jul 09, 2001
EASY CONTROL MICRO INSERTER, MODEL ON385
K011498 · NCE
Ophtec USA, Inc.
Ophthalmic · 55d