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FDA 510(k) Application Details - K210634
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K210634
Device Name
Powered Laser Surgical Instrument
Applicant
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena 07747 DE
Other 510(k) Applications for this Company
Contact
Dania Di Pietro Paolo
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2021
Decision Date
04/13/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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