ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060


Device Classification Name

powered laser surgical instrument

510(k) Number K072182
Device Name ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
Applicant
ALMA LASERS LTD.
3637 bernal ave.
pleasanton, 
CA 
94566

Applicant Contact anne worden
Correspondent
ALMA LASERS LTD.
3637 bernal ave.
pleasanton, 
CA 
94566

Correspodent Contact anne worden
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/06/2007
Decision Date 06/27/2008
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