ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES


Device Classification Name

powered laser surgical instrument

510(k) Number K080463
Device Name ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
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 02/20/2008
Decision Date 07/23/2008
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