ME HAIR2GO


Device Classification Name

powered light based non-laser surgical instrument with thermal effect

510(k) Number K121598
Device Name ME HAIR2GO
Applicant
SYNERON MEDICAL LTD.
1835 market st, 29th floor
philadelphia, 
PA 
19103

Applicant Contact janice m hogan
Correspondent
SYNERON MEDICAL LTD.
1835 market st, 29th floor
philadelphia, 
PA 
19103

Correspodent Contact janice m hogan
Regulation Number 878.4810
Classification Product Code
ONF  
Date Received 05/31/2012
Decision Date 10/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No