SPPHINE PLUS STM 3W DIODE LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K110079
Device Name SPPHINE PLUS STM 3W DIODE LASER
Applicant
DEN-MAT HOLDINGS, LLC
2727 skyway dr.
santa maria, 
CA 
93455

Applicant Contact alan b metthews
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/11/2011
Decision Date 02/10/2011
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