FDA 510(k) Application Details - K223642

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K223642
Device Name Lamp, Infrared, Therapeutic Heating
Applicant Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague NL
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Contact Alain Dijkstra
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/06/2022
Decision Date 03/09/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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