Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K123168 |
Device Name |
Q-PLUS T+ IPL LASER SYSTEM |
Applicant |
Quanta System SpA |
VIA IV NOVEMBRE, 116 |
SOLBIATE OLONA, VA,
IT
21058
|
|
Applicant Contact |
Maurizio Bianchi |
Correspondent |
Quanta System SpA |
VIA IV NOVEMBRE, 116 |
SOLBIATE OLONA, VA,
IT
21058
|
|
Correspondent Contact |
Maurizio Bianchi |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/09/2012 |
Decision Date | 12/20/2012 |
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
|
Recalls |
CDRH Recalls
|