LUXTEC MLX LIGHT SOURCE


Device Classification Name

light source, fiberoptic, routine

510(k) Number K081477
Device Name LUXTEC MLX LIGHT SOURCE
Applicant
INTEGRA LUXTEC, INC.
99 hartwell st.
west boylston, 
MA 
01583

Applicant Contact rita wadleigh
Correspondent
INTEGRA LUXTEC, INC.
99 hartwell st.
west boylston, 
MA 
01583

Correspodent Contact rita wadleigh
Regulation Number 876.1500
Classification Product Code
FCW  
Date Received 05/27/2008
Decision Date 06/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls