LIGHTWAVE INFRARED LAMPS LW10D AND LW30D


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K024027
Device Name LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
Original Applicant
SKYTECH ENTERPRISES, INC.
4655 kirkwood court
boulder, 
CO 
80301

Original Contact lewis ward
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 12/06/2002
Decision Date 12/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No