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
1729–1752 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 14, 2000
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
K993489 · LPL
Crystal Reflections, Int., Inc.
Ophthalmic · 182d
Cleared Apr 12, 2000
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
K000127 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 85d
Cleared Apr 11, 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · MRC
Alcon Laboratories
Ophthalmic · 84d
Cleared Apr 10, 2000
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
K000151 · MQU
Integrated Orbital Implants, Inc.
Ophthalmic · 82d
Cleared Mar 31, 2000
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
K000731 · HLI
Talia Technology , Ltd.
Ophthalmic · 25d
Cleared Mar 23, 2000
REICHERT CT200 CONTACT TONOMETER
K000288 · HKY
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 52d
Cleared Mar 21, 2000
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY...
K000376 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 43d
Cleared Mar 21, 2000
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT...
K000529 · LPL
The Lifestyle Co., Inc.
Ophthalmic · 33d
Cleared Mar 20, 2000
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES,...
K000439 · LPL
Wesley Jessen Corp.
Ophthalmic · 39d
Cleared Mar 20, 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR...
K991840 · HKY
Bernard B. Fresco
Ophthalmic · 297d
Cleared Mar 20, 2000
BLADEWORKS MICROKERATOME BLADE
K993225 · HNO
Blade Works, Inc.
Ophthalmic · 175d
Cleared Mar 20, 2000
IOLMASTER
K993357 · HJO
Carl Zeiss, Inc.
Ophthalmic · 166d
Cleared Mar 20, 2000
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
K994335 · LPL
Wesley Jessen Corp.
Ophthalmic · 88d
Cleared Mar 16, 2000
MSP M/K BLADE
K993122 · HNO
Medical Sterile Products, Inc.
Ophthalmic · 178d
Cleared Mar 15, 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 110d
Cleared Mar 09, 2000
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
K000544 · HJX
Labtician Ophthalmics, Inc.
Ophthalmic · 20d
Cleared Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Mar 03, 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
K994125 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 87d
Cleared Mar 02, 2000
HYLASHIELD CL
K994170 · MRC
Biomatrix, Inc.
Ophthalmic · 83d
Cleared Feb 23, 2000
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY...
K994318 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 23, 2000
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY...
K994324 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 22, 2000
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
K994021 · LYL
Strieter Clinical Research...
Ophthalmic · 88d
Cleared Feb 10, 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT...
K993190 · HNO
Surgical Instrument Systems (Sis), Ltd.
Ophthalmic · 140d
Cleared Feb 02, 2000
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
K992787 · HQD
Specialty Ultravision, Inc.
Ophthalmic · 167d