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510(k) K131259

LASER-STIM by Shenzhen Dongdixin Technology Co., Ltd. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2013
Date Received
May 2, 2013
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

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