510(k) K083580

ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 by Led Intellectual Properties, LLC — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2009
Date Received
December 3, 2008
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