SPECTRA THERAPY SYSTEM A1000 LASER DEVICE


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K080689
Device Name SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
Applicant
PREMIER DYNAMICS, INC.
3863 rochester road
troy, 
MI 
48083

Applicant Contact john j stephan
Correspondent
PREMIER DYNAMICS, INC.
3863 rochester road
troy, 
MI 
48083

Correspodent Contact john j stephan
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 03/11/2008
Decision Date 07/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No