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
817–840 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 13, 2013
STANDARD CONTACT LENS CASE
K130753 · LRX
Watchdog Group, LC
Ophthalmic · 86d
Cleared Jun 05, 2013
TRC-50DX RETINAL CAMERA
K123101 · HKI
Topcon Medical Systems, Inc.
Ophthalmic · 244d
Cleared May 31, 2013
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
K122700 · LRX
Prosben, Inc.
Ophthalmic · 269d
Cleared May 30, 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · LPL
CooperVision, Inc.
Ophthalmic · 230d
Cleared May 16, 2013
CRYSTALSERT DELIVERY SYSTEM
K123736 · MSS
Bausch & Lomb
Ophthalmic · 162d
Cleared May 15, 2013
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
K123542 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 177d
Cleared CT May 15, 2013
SAUFLON MULTIPURPOSE SOLUTION
K130734 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 58d
Cleared CT May 13, 2013
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON...
K120756 · LPL
The Lagado Corp.
Ophthalmic · 426d
Cleared May 10, 2013
BOSTON KERATOPROSTHESIS OR BOSTON KPRO
K121203 · HQM
Massachusetts Eye & Ear Infirmary
Ophthalmic · 385d
Cleared May 10, 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289 · HKI
Topcon Corp.
Ophthalmic · 94d
Cleared Apr 30, 2013
PEREGRINE 23GA CURVED LASER PROBE
K122905 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 221d
Cleared Apr 23, 2013
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K123973 · LPL
Pegavision Corporation
Ophthalmic · 118d
Cleared Apr 15, 2013
Z CARTRIDGE IOL DELIVERY SYSTEM
K123888 · MSS
Aaren Scientific, Inc.
Ophthalmic · 118d
Cleared Apr 12, 2013
IOLMASTER 500
K122418 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared Apr 03, 2013
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K130285 · LRX
The Lagado Corp.
Ophthalmic · 57d
Cleared Apr 02, 2013
EXCELSIOR
K130453 · NFJ
Eyekor, LLC
Ophthalmic · 39d
Cleared Mar 29, 2013
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON...
K123484 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 136d
Cleared Mar 27, 2013
TBD
K123859 · OOE
Lensar, Inc.
Ophthalmic · 103d
Cleared Mar 22, 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
K123587 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Mar 19, 2013
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS...
K122220 · LPL
Soflex Limited
Ophthalmic · 237d
Cleared Mar 19, 2013
DIGITAL RETINAL CAMERA
K123208 · HKI
Canon Inc. -Medical Equipment Group
Ophthalmic · 158d
Cleared Mar 14, 2013
NIDEK RS-3000
K121622 · OBO
Nidek Co., Ltd.
Ophthalmic · 286d
Cleared Mar 05, 2013
CALLISTO EYE
K123464 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 116d
Cleared Feb 26, 2013
HEINE OMEGA 500
K123316 · HLI
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 124d