CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS

Device Classification Name

powered laser surgical instrument

510(k) Number K033172
Device Name CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
Applicant
CANDELA CORP.
530 boston post rd.
wayland, 
MA 
01778

Applicant Contact lorraine calzetta-patrovic
Correspondent
CANDELA CORP.
530 boston post rd.
wayland, 
MA 
01778

Correspodent Contact lorraine calzetta-patrovic
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 09/30/2003
Decision Date 10/30/2003
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