ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM


Device Classification Name

powered laser surgical instrument

510(k) Number K072564
Device Name ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
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  
Subsequent Product Codes
FTC   HHR   LNK  
Date Received 09/11/2007
Decision Date 05/23/2008
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