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
793–816 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 30, 2013
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
K130931 · LPL
Jiangsu Horien Contact Lens Co., Ltd.
Ophthalmic · 148d
Cleared Aug 30, 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · LPL
CooperVision, Inc.
Ophthalmic · 108d
Cleared Aug 30, 2013
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT...
K132146 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 50d
Cleared Aug 06, 2013
MENICON NECT CONTACT LENS CASE
K131875 · LRX
Foresight Regulatory Strategies
Ophthalmic · 43d
Cleared Aug 05, 2013
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
K130342 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 175d
Cleared Aug 02, 2013
SOLUTIS
K130933 · HQF
Quantel Medical
Ophthalmic · 120d
Cleared Jul 29, 2013
OPHTACATH KIT
K123831 · OKS
France Chirurgae Instrumentation
Ophthalmic · 229d
Cleared Jul 26, 2013
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE...
K130331 · MVN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
K130648 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 134d
Cleared Jul 03, 2013
IFUSION
K130656 · HKI
Optovue, Inc.
Ophthalmic · 113d
Cleared Jul 03, 2013
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
K130805 · MRC
Menicon Co, Ltd.
Ophthalmic · 100d
Cleared Jul 01, 2013
ELLEX 2RT
K122202 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 341d
Cleared Jun 27, 2013
KEELER SLIT LAMP H-SERIES
K131589 · HJO
Keeler, Ltd.
Ophthalmic · 27d
Cleared Jun 26, 2013
23GA CURVED ILLUMINATING LASER PROBE
K122997 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 272d
Cleared Jun 17, 2013
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II...
K123431 · LPL
Dreamcon Co., Ltd.
Ophthalmic · 222d
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 May 15, 2013
SAUFLON MULTIPURPOSE SOLUTION
K130734 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 58d
Cleared 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