ALMA LASER NIR MODULE


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K080318
Device Name ALMA LASER NIR MODULE
Applicant
ALMA LASERS LTD.
halamish st. pob 3021
industrial park
caesarea, 

IL

38900

Applicant Contact tatiana epstein
Correspondent
ALMA LASERS LTD.
halamish st. pob 3021
industrial park
caesarea, 

IL

38900

Correspodent Contact tatiana epstein
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 02/06/2008
Decision Date 03/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No