NLITE SYSTEM, MODEL#: A00-1025/A00-1033


Device Classification Name

powered laser surgical instrument

510(k) Number K024189
Device Name NLITE SYSTEM, MODEL#: A00-1025/A00-1033
Original Applicant
ICN PHOTONICS LTD.
units 1&2 heol rhosyn,
dafen park
llanelli, 

GB

sa148qg

Original Contact mike kierman
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/19/2002
Decision Date 06/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No