TATTOOSTAR EFFECT Y


Device Classification Name

powered laser surgical instrument

510(k) Number K112669
Device Name TATTOOSTAR EFFECT Y
Applicant
ASCLEPION LASER TECHNOLOGIES GMBH
bruesseler str. 10
jena, 

DE

07747

Applicant Contact antje katzer
Correspondent
ASCLEPION LASER TECHNOLOGIES GMBH
bruesseler str. 10
jena, 

DE

07747

Correspodent Contact antje katzer
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 09/14/2011
Decision Date 05/11/2012
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