IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM


Device Classification Name

light based over-the-counter hair removal

510(k) Number K122280
Device Name IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
Applicant
CYDEN LIMITED
2001 pennsylania ave
suite 950
washington, 
DC 
20006

Applicant Contact austin speier
Correspondent
CYDEN LIMITED
2001 pennsylania ave
suite 950
washington, 
DC 
20006

Correspodent Contact austin speier
Regulation Number 878.4810
Classification Product Code
OHT  
Date Received 07/30/2012
Decision Date 10/23/2012
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