OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A


the company

Device Classification Name

powered laser surgical instrument

510(k) Number K002308
Device Name OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
Original Applicant
TRIMEDYNE, INC.
2801 barranca rd.
p.o. box 57001
irvine, 
CA 
92619 -7001

Original Contact susan h gamble
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/28/2000
Decision Date 12/20/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No