VISULAS TRION


Device Classification Name

powered laser surgical instrument

510(k) Number K072514
Device Name VISULAS TRION
Applicant
CARL ZEISS MEDITEC AG
5160 hacienda drive
dublin, 
CA 
94568

Applicant Contact kent w jones
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 09/07/2007
Decision Date 09/21/2007
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