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510(k) K231997

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) by Cure Point Therapeutics, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2024
Date Received
July 5, 2023
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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