FDA 510(k) Applications Submitted by RICHARD Y LI, PH.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130305 |
02/05/2013 |
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE |
LINA MEDICAL APS |
| K131176 |
04/25/2013 |
ROSS RU SKIN DISCONTINUITIES |
BIOTD, S.A. |
| K141637 |
06/19/2014 |
SPB SKIN EMULSION |
BIOTD, S.A. |
| K962180 |
06/06/1996 |
CATH SEAL |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
| K012425 |
07/30/2001 |
BIOMEDICS UV MULTIFOCAL |
OCULAR SCIENCES PUERTO RICO, INC. |
| K013377 |
10/12/2001 |
BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
| K993580 |
10/22/1999 |
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
SPECIALTY ULTRAVISION, INC. |
| K180065 |
01/09/2018 |
FUSION Plus Curing Light |
DentLight Inc. |
| K101140 |
04/22/2010 |
DENTLIGHT ORAL EXAM LIGHT KIT |
DENTLIGHT INC. |
| K201387 |
05/27/2020 |
Ultrafast, Ultrafast Plus, Ultrafast Lite |
DentLight Inc. |
| K052593 |
09/21/2005 |
FUSION CURING LIGHT |
DENTLIGHT INC. |
| K021700 |
05/23/2002 |
ANIMUS EZSERTER INFUSION SET INSERTER |
ANIMAS CORP. |
| K050228 |
02/01/2005 |
AGFA HEARTLAB CARDIOVASCULAR |
HEARTLAB, INC. |
| K050858 |
04/05/2005 |
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM |
HEARTLAB, INC. |
| K040896 |
04/06/2004 |
MODIFICATION TO ENCOMPASS |
HEARTLAB, INC. |
| K042042 |
07/29/2004 |
ULTRASOUND CAPTURE SYSTEM |
HEARTLAB, INC. |
| K954479 |
09/26/1995 |
DICOMVIEW |
HEARTLAB, INC. |
| K062021 |
07/17/2006 |
KOWA VX-10I |
KOWA CO. LTD. |
| K063759 |
12/19/2006 |
HEATMARKER TIME TEMPERATURE INDICATOR |
TEMPTIME CORPORATION |
| K980836 |
03/04/1998 |
GENIE CUP INTEGRATED SCREENING DEVICE |
APPLIED TECHNOLOGY VENTURES, L.L.C. |
| K973726 |
09/30/1997 |
FINGERPRINT DRUG SCREENING DEVICE |
APPLIED TECHNOLOGY VENTURES, L.L.C. |
| K053257 |
11/22/2005 |
PARA-PRO FC50 |
ALPHA-TEC SYSTEMS, INC. |
| K002813 |
09/08/2000 |
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORP. |
| K032777 |
09/08/2003 |
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORP. |
| K023007 |
09/09/2002 |
DISTAL RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
| K010264 |
01/29/2001 |
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET |
NIPRO MEDICAL CORP. |
| K030198 |
01/21/2003 |
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
| K981622 |
05/07/1998 |
DADE TRU-LIQUID CARDIAC CONTROL |
DADE BEHRING, INC. |
| K001465 |
05/10/2000 |
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET |
NIPRO MEDICAL CORP. |
| K060102 |
01/13/2006 |
SYNERGEYES PS HYBRID CONTACT LENS |
Synergeyes, Inc. |
| K020193 |
01/18/2002 |
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
CL MCINTOSH |
| K080193 |
01/25/2008 |
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR |
Synergeyes, Inc. |
| K020389 |
02/05/2002 |
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
OCULAR SCIENCES |
| K050350 |
02/11/2005 |
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) |
NOTAL VISION, INC. |
| K050623 |
03/10/2005 |
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D |
VOLK OPTICAL, INC. |
| K081034 |
04/11/2008 |
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS |
Synergeyes, Inc. |
| K051035 |
04/22/2005 |
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS |
SYNERGEYES |
| K031477 |
05/09/2003 |
HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS |
OCULAR SCIENCES, INC. |
| K021699 |
05/22/2002 |
AUTOLENS CLEANING AND DISINFECTING UNIT |
AUTOLENS INC. |
| K991965 |
06/10/1999 |
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES |
PURILENS, INC. |
| K071755 |
06/28/2007 |
FALCK APPLANATION TONOMETER (FAT2) |
FALCK MEDICAL INC. |
| K992264 |
07/06/1999 |
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
| K032309 |
07/25/2003 |
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY |
NOVELENS, INC. |
| K012530 |
08/06/2001 |
AA-1 SYSTEM |
NEUROVISION, INC. |
| K982947 |
08/21/1998 |
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
| K012852 |
08/24/2001 |
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS |
OPTONOL, LTD |
| K023221 |
09/27/2002 |
CONTACT LASER & DIAGNOSTIC LENSES |
VOLK OPTICAL, INC. |
| K052675 |
09/27/2005 |
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS |
SYNERGEYES |
| K003136 |
10/06/2000 |
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
| K964289 |
10/28/1996 |
EYE FIXATION SPECULUM |
EYEFIX, INC. |
| K984046 |
11/12/1998 |
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
| K113586 |
12/05/2011 |
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS |
Synergeyes, Inc. |
| K014044 |
12/07/2001 |
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) |
NOTAL VISION, INC. |
| K083921 |
12/31/2008 |
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS |
Synergeyes, Inc. |
| K061120 |
04/21/2006 |
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES |
Synergeyes, Inc. |
| K970170 |
01/09/1997 |
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE |
RICHARD G. LINDSAY |
| K963287 |
08/21/1996 |
VACUUM CUP (004SD) |
SWIFT DELIVERY PRODUCTS |
| K973942 |
09/26/1997 |
SWIFT DELIVERY PRODUCT #300 |
SWIFT DELIVERY PRODUCTS |
| K013460 |
10/18/2001 |
SWIFT LOW PROFILE CUP (PRO CUP) |
SWIFT DELIVERY PRODUCTS |
| K032076 |
07/07/2003 |
SENOVA(R) BLOOD GLUCOSE MONITOR |
CHDIAGNOSTICS LLC |
| K043213 |
11/19/2004 |
KOWA VX-10 |
KOWA CO. LTD. |
| K971929 |
05/27/1997 |
AMSINO URINARY LEG BAG |
AMSINO INTL., INC. |
| K992719 |
08/12/1999 |
AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE |
AMSINO INTL., INC. |
| K973107 |
08/19/1997 |
AMSINO I.V. ADMINISTRATION SET |
AMSINO INTL., INC. |
| K973199 |
08/26/1997 |
AMSINO SUCTION CATHETER |
AMSINO INTL., INC. |
| K974042 |
10/24/1997 |
AMSURE CLEANSING ENEMA SET |
AMSINO INTL., INC. |
| K960185 |
01/16/1996 |
AMSINO CLINICAL THERMOMETER |
AMSIA INTL., INC. |
| K964745 |
11/26/1996 |
AMSINO URINARY DRAINAGE BAG |
AMSINO INTL., INC. |
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