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
1513–1536 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 21, 2002
VISUCAM
K021787 · NFF
Carl Zeiss Ophthalmic Systems, Inc.
Ophthalmic · 22d
Cleared Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
K021640 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Jun 04, 2002
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K020389 · MVN
Ocular Sciences
Ophthalmic · 119d
Cleared Jun 04, 2002
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL...
K020855 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 81d
Cleared Jun 04, 2002
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K021295 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 41d
Cleared May 31, 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K020802 · LYL
Bausch & Lomb, Incorporated
Ophthalmic · 80d
Cleared May 30, 2002
ROSE K POST GRAFT LENS
K013646 · HQD
Rose K International , Ltd.
Ophthalmic · 206d
Cleared May 24, 2002
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS...
K020642 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 86d
Cleared May 16, 2002
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY...
K020608 · LPL
Poly Vue Technolgies, Inc.
Ophthalmic · 80d
Cleared May 16, 2002
SURGE-FREE ASPIRATION ADAPTER
K020734 · HQC
Staar Surgical Co.
Ophthalmic · 71d
Cleared May 16, 2002
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
K020927 · LPL
Bausch & Lomb
Ophthalmic · 56d
Cleared May 09, 2002
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
K012132 · NIC
Cantor & Nissel , Ltd.
Ophthalmic · 304d
Cleared May 06, 2002
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K020917 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 46d
Cleared May 03, 2002
OCULIGHT SL/SLX
K020374 · HQF
Iridex Corp
Ophthalmic · 88d
Cleared May 02, 2002
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · MRC
Menicon Co, Ltd.
Ophthalmic · 41d
Cleared Apr 29, 2002
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
K020911 · HQE
Medical Instrument Development...
Ophthalmic · 40d
Cleared Apr 26, 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · LPL
CooperVision, Inc.
Ophthalmic · 79d
Cleared Apr 26, 2002
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
K020690 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 53d
Cleared Apr 25, 2002
PVS BASIC 2
K013310 · HQD
Paragon Vision Sciences
Ophthalmic · 203d
Cleared Apr 19, 2002
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
K020079 · HNO
Blade Works, Inc.
Ophthalmic · 99d
Cleared Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · HKI
Nidek, Inc.
Ophthalmic · 111d
Cleared Apr 09, 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
K020139 · LPL
Ciba Vision Corporation
Ophthalmic · 83d
Cleared Apr 03, 2002
AQUIFY LENS COMFORT DROPS
K013204 · MRC
Ciba Vision Corporation
Ophthalmic · 190d
Cleared Apr 03, 2002
RIGID GAS PERMEABLE CONTACT LENS
K013762 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 141d