C100 WRINKLE REDUCTION DEVICE


Device Classification Name

light based over the counter wrinkle reduction

510(k) Number K112362
Device Name C100 WRINKLE REDUCTION DEVICE
Applicant
SILVER BAY, LLC
1131 anthem view lane
knoxville, 
TN 
37922

Applicant Contact robert wagner
Correspondent
SILVER BAY, LLC
1131 anthem view lane
knoxville, 
TN 
37922

Correspodent Contact robert wagner
Regulation Number 878.4810
Classification Product Code
OHS  
Date Received 08/17/2011
Decision Date 08/14/2012
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