SOFTLASE G2-SURGICAL DIODE LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K021227
Device Name SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
Original Applicant
ZAP LASERS, LLC
2643 pleasant hill rd.
pleasant hill, 
CA 
94523

Original Contact jay goble
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/18/2002
Decision Date 06/26/2002
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