QUASAR CALYPSO


Device Classification Name

over-the-counter powered light based laser for acne

510(k) Number K111286
Device Name QUASAR CALYPSO
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
OLP  
Date Received 05/06/2011
Decision Date 01/18/2012
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