ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES


Device Classification Name

powered laser surgical instrument

510(k) Number K103501
Device Name ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
Applicant
ALMA LASERS, INC.
485 half day rd.
suite #100
buffalo grove, 
IL 
60089

Applicant Contact tatiana epstein
Correspondent
ALMA LASERS, INC.
485 half day rd.
suite #100
buffalo grove, 
IL 
60089

Correspodent Contact tatiana epstein
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 11/29/2010
Decision Date 01/14/2011
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