SILK’N FX


Device Classification Name

light based over the counter wrinkle reduction

510(k) Number K110301
FOIA Releasable 510(k) K110301
Device Name SILK’N FX
Applicant
HOME SKINOVATIONS LTD.
tavor buld. pob 533
yokneam illit, 

IL

20692

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

IL

20692

Correspodent Contact amir waldman ph. d.
Regulation Number 878.4810
Classification Product Code
OHS  
Date Received 02/02/2011
Decision Date 08/19/2011
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