FLASH 1


Device Classification Name

powered laser surgical instrument

510(k) Number K022583
Device Name FLASH 1
Original Applicant
EMED, INC.
191 west wilbur rd.
suite 103
thousand oaks, 
CA 
91360

Original Contact kenneth karasiuk
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/05/2002
Decision Date 10/31/2002
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