CANDELA GENTLE YAG LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K022923
Device Name CANDELA GENTLE YAG LASER SYSTEM
Original Applicant
CANDELA CORP.
530 boston post rd.
wayland, 
MA 
01778

Original Contact lorraine nelson
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 09/04/2002
Decision Date 03/13/2003
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