Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K121920 |
Device Name |
LASERBRUSH |
Applicant |
SUNETICS INTERNATIONAL MARKETING GROUP, LLC |
892 STEGER TOWNE RD #44 |
ROCKWALL,
TX
75032
|
|
Applicant Contact |
JOHN CARULLO |
Correspondent |
SUNETICS INTERNATIONAL MARKETING GROUP, LLC |
892 STEGER TOWNE RD #44 |
ROCKWALL,
TX
75032
|
|
Correspondent Contact |
JOHN CARULLO |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 06/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|