FDA 510(k) Applications for Medical Device Product Code "PDZ"
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K113810 |
ALMA LASERS INC. |
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES |
03/08/2012 |
K150138 |
ASPEN LASER SYSTEMS, LLC |
Aspen Laser Systems Therapy Laser System |
05/08/2015 |
K110375 |
BLUESHINE SRL |
BLUESHINE'S GOLD SERIES |
02/23/2012 |
K103626 |
CUTERA, INC. |
CUTERA GENESISPLUS LASER SYSTEM |
04/05/2011 |
K153164 |
ERCHONIA MEDICAL, INC. |
LunulaLaser |
06/03/2016 |
K190034 |
Footdocprenur, LLC |
REMY Medical Therapy Laser System |
05/15/2019 |
K113702 |
FOTONA D.D. |
FOTONA XP ND: YAG LASER SYSTEM |
03/28/2012 |
K121508 |
FOTONA D.D. |
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N |
12/12/2012 |
K110370 |
LIGHT AGE, INC. |
Q-CLEAR |
09/15/2011 |
K123014 |
LITECURE, LLC |
LITECURE THERAPY SYSTEM MODEL LTS-1500 |
03/29/2013 |
K113843 |
LUTRONIC CORPORATION |
FREEDOM ND: YAG LASER SYSTEM |
09/27/2012 |
K103338 |
NEW STAR LASERS, INC. |
COOLTOUCH |
11/01/2011 |
K093547 |
PINPOINTE USA, INC. |
PINPOINTE FOOTLASER |
10/15/2010 |
K111483 |
SCITON, INC. |
JOULE CLEARSENSE LASER SYSTEM |
12/07/2011 |
K120938 |
SHEAUMANN LASER, INC |
THE PL-1064 LASER SYSTEM |
09/24/2012 |
K221363 |
ShenB Co Ltd |
AF Laser |
07/20/2022 |
K211265 |
ToeFX, Inc. |
TFX-LT2000 Therapy Light |
11/17/2022 |
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