SILKN BLUE


Device Classification Name

over-the-counter powered light based laser for acne

510(k) Number K121435
Device Name SILKN BLUE
Applicant
HOME SKINOVATIONS LTD.
tavor buld. pob 533
yokneam illit, 

IL

20692

Applicant Contact amir waldman
Correspondent
HOME SKINOVATIONS LTD.
tavor buld. pob 533
yokneam illit, 

IL

20692

Correspodent Contact amir waldman
Regulation Number 878.4810
Classification Product Code
OLP  
Date Received 05/14/2012
Decision Date 02/22/2013
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