CANDELA GENTLELASE FAMILY OF LASERS


Device Classification Name

powered laser surgical instrument

510(k) Number K111144
Device Name CANDELA GENTLELASE FAMILY OF LASERS
Applicant
CANDELA CORP.
530 boston post road
wayland, 
MA 
01778

Applicant Contact scott blood
Correspondent
CANDELA CORP.
530 boston post road
wayland, 
MA 
01778

Correspodent Contact scott blood
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/22/2011
Decision Date 07/18/2011
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

Recalls CDRH Recalls