Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K150613 |
Device Name |
LaserCap LC Pro and LC Elite |
Applicant |
TRANSDERMAL CAP, INC. |
3615 SUPERIOR AVENUE, SUITE 3104F |
CLEVELAND,
OH
44114
|
|
Applicant Contact |
MICHAEL RABIN |
Correspondent |
NST CONSULTING, LLC |
641 SHUNPIKE ROAD, SUITE 311 |
CHATHAM,
NJ
07928
|
|
Correspondent Contact |
RAYMOND R. BLANCHE |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 03/10/2015 |
Decision Date | 07/22/2015 |
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
|
|
|