SPHINX LASER SYSTEMS


Device Classification Name

powered laser surgical instrument

510(k) Number K033437
Device Name SPHINX LASER SYSTEMS
Applicant
ALLMED SYSTEMS INC.
9232 klemetson drive
pleasanton, 
CA 
94588

Applicant Contact peter allen
Correspondent
ALLMED SYSTEMS INC.
9232 klemetson drive
pleasanton, 
CA 
94588

Correspodent Contact peter allen
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/28/2003
Decision Date 01/20/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No