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FDA 510(k) Application Details - K230990
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K230990
Device Name
Powered Laser Surgical Instrument
Applicant
Candela Corporation
251 Locke Drive
Marlborough, MA 01752 US
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Contact
Danielle Gibboney
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
04/06/2023
Decision Date
06/01/2023
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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