Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K120737 |
Device Name |
TRIA LASER HAIR REMOVAL SYSTEM |
Applicant |
TRIA BEAUTY, INC. |
555 13TH STREET, NW |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN KAHAN |
Correspondent |
TRIA BEAUTY, INC. |
555 13TH STREET, NW |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN KAHAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/09/2012 |
Decision Date | 09/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|