TRIXEL CO2 LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K110434
Device Name TRIXEL CO2 LASER
Applicant
BEIJING SYNTECH LASER CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/15/2011
Decision Date 04/19/2011
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