CLEANE / CLEANE POP


Device Classification Name

over the counter thermal treatment for acne.

510(k) Number K111341
Device Name CLEANE / CLEANE POP
Applicant
MEDICON CO., LTD.
951 starbuck st.
unit j
fullerton, 
CA 
92833

Applicant Contact priscilla chung
Correspondent
MEDICON CO., LTD.
951 starbuck st.
unit j
fullerton, 
CA 
92833

Correspodent Contact priscilla chung
Regulation Number 890.5740
Classification Product Code
OZC  
Date Received 05/12/2011
Decision Date 02/29/2012
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