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510(k) K221189

OLIZ LTB-1000A by Ltbio Co., Ltd. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2022
Date Received
April 25, 2022
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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