HAIRMAX DUAL 12


Device Classification Name

laser, comb, hair

510(k) Number K111714
Device Name HAIRMAX DUAL 12
Applicant
LEXINGTON INTERNATIONAL, LLC
1400 sixteenth street, nw
suite 400
washington, 
DC 
20036

Applicant Contact casper e uldricks esq.
Correspondent
LEXINGTON INTERNATIONAL, LLC
1400 sixteenth street, nw
suite 400
washington, 
DC 
20036

Correspodent Contact casper e uldricks esq.
Regulation Number 890.5500
Classification Product Code
OAP  
Date Received 06/20/2011
Decision Date 08/16/2011
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