510(k) K040662

VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS by Chattanooga Group — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2004
Date Received
March 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type