Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K110233 |
Device Name |
HAIRMAX LASERCOMB |
Applicant |
LEXINGTON INTERNATIONAL, LLC |
1400 SIXTEENTH STREET, NW |
SUITE 400 |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
CASPER E ULDRIKS ESQ. |
Correspondent |
LEXINGTON INTERNATIONAL, LLC |
1400 SIXTEENTH STREET, NW |
SUITE 400 |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
CASPER E ULDRIKS ESQ. |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 01/26/2011 |
Decision Date | 05/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Clinical Trials |
NCT00981461
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|