RADIANCY MISTRAL DEVICE


Device Classification Name

powered laser surgical instrument

510(k) Number K072331
Device Name RADIANCY MISTRAL DEVICE
Applicant
RADIANCY (ISRAEL) LTD.
990 washington st.
dedham, 
MA 
02026

Applicant Contact zvi ladin
Correspondent
RADIANCY (ISRAEL) LTD.
990 washington st.
dedham, 
MA 
02026

Correspodent Contact zvi ladin
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/20/2007
Decision Date 01/07/2008
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