SILK’N


Device Classification Name

powered laser surgical instrument

510(k) Number K072906
Device Name SILK’N
Applicant
HOME SKINOVATIONS LTD.
4 hacharoshet st.
pob 7028
kfar saba, 

IL

44640

Applicant Contact amir waldman
Correspondent
HOME SKINOVATIONS LTD.
4 hacharoshet st.
pob 7028
kfar saba, 

IL

44640

Correspodent Contact amir waldman
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/11/2007
Decision Date 01/23/2008
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