STYLA MICROLASER AND STYLAORTHO


Device Classification Name

powered laser surgical instrument

510(k) Number K081214
Device Name STYLA MICROLASER AND STYLAORTHO
Applicant
ZAP LASERS, LLC
2621 pleasant hill rd.
pleasant hill, 
CA 
94523

Applicant Contact jay goble
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/30/2008
Decision Date 05/14/2008
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