SHASER IPL HAIR REMOVAL SYSTEM


Device Classification Name

powered light based non-laser surgical instrument with thermal effect

510(k) Number K103560
Device Name SHASER IPL HAIR REMOVAL SYSTEM
Applicant
SHASER, INC.
32 harrison st.
melrose, 
MA 
02176

Applicant Contact glen emelock
Correspondent
SHASER, INC.
32 harrison st.
melrose, 
MA 
02176

Correspodent Contact glen emelock
Regulation Number 878.4810
Classification Product Code
ONF  
Date Received 12/03/2010
Decision Date 05/18/2011
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