PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X


Device Classification Name

powered laser surgical instrument

510(k) Number K002228
Device Name PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
Original Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
2355 south 1070 west
salt lake city, 
UT 
84119

Original Contact tracy s best
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/24/2000
Decision Date 10/06/2000
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