Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K060305 |
Device Name |
HAIRMAX LASERCOMB |
Applicant |
LEXINGTON INTERNATIONAL, LLC |
1700 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
EDWARD BASILE |
Correspondent |
LEXINGTON INTERNATIONAL, LLC |
1700 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
EDWARD BASILE |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 02/06/2006 |
Decision Date | 01/18/2007 |
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
|
|
|