ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION


Device Classification Name

powered laser surgical instrument

510(k) Number K112031
Device Name ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
Applicant
ALMA LASERS, INC.
485 half day rd.
suite no. 100
buffalo grove, 
IL 
60089

Applicant Contact anne worden
Correspondent
ALMA LASERS, INC.
485 half day rd.
suite no. 100
buffalo grove, 
IL 
60089

Correspodent Contact anne worden
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/15/2011
Decision Date 09/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No