FDA 510(k) Applications Submitted by Connie Hoy
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070138 |
01/16/2007 |
CUTERA ER:YAG LASER HANDPIECE |
CUTERA, INC. |
| K060338 |
02/10/2006 |
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO |
LUMENIS, INC. |
| K100487 |
02/19/2010 |
EQUINOX CO2 LASER SYSTEM |
ECLIPSEMED GLOBAL, INC |
| K051214 |
05/12/2005 |
ALUMA SKIN RENEWAL SYSTEM |
LUMENIS, INC. |
| K032191 |
07/17/2003 |
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM |
LUXSANO AB |
| K122389 |
08/07/2012 |
TRUSCULPT |
CUTERA, INC. |
| K122493 |
08/16/2012 |
GENESISPLUS |
CUTERA, INC. |
| K102954 |
10/05/2010 |
CUTERA QSWITCH LASER SYSTEM |
CUTERA, INC. |
| K133364 |
11/01/2013 |
PICOSURE WORKSTATION |
CYNOSURE, INC. |
| K103626 |
12/10/2010 |
CUTERA GENESISPLUS LASER SYSTEM |
CUTERA, INC. |
| K073477 |
12/11/2007 |
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS |
PHOTONOVA OFSWEDEN AB |
| K053628 |
12/29/2005 |
LIGHTSHEER DUET LASER SYSTEM |
LUMENIS, INC. |
| K063867 |
12/29/2006 |
CUTERA ER:YSGG LASER HANDPIECE |
CUTERA, INC. |
| K040563 |
03/03/2004 |
LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K000929 |
03/22/2000 |
PROLITE PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
| K041011 |
04/20/2004 |
ULTRALIGHT II ND:YAG LASER SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K002072 |
07/07/2000 |
PROLITE VL PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
| K022378 |
07/22/2002 |
PLASMALITE PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
| K022568 |
08/02/2002 |
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR |
MEDICAL BIO CARE SWEDEN AB |
| K022569 |
08/02/2002 |
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS |
MEDICAL BIO CARE SWEDEN AB |
| K004021 |
12/27/2000 |
F1 DIODE LASER SYSTEM |
OPUS MEDICAL, INC. |
| K013365 |
10/10/2001 |
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS |
MEDICAL BIO CARE SWEDEN AB |
| K013366 |
10/10/2001 |
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR |
MEDICAL BIO CARE SWEDEN AB |
| K010927 |
03/28/2001 |
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
| K010928 |
03/28/2001 |
PROLITE VL PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
| K023081 |
09/17/2002 |
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) |
MEDICAL BIO CARE SWEDEN AB |
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