SAPPHIRE ST PORTABLE DIODE LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K103667
Device Name SAPPHIRE ST PORTABLE DIODE LASER
Applicant
DEN-MAT HOLDINGS, LLC
2727 skyway dr.
santa maria, 
CA 
93455

Applicant Contact alan b matthews
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/15/2010
Decision Date 12/29/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No