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FDA 510(k) Application Details - K183452
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K183452
Device Name
Powered Laser Surgical Instrument
Applicant
Candela Corp.
530 Boston Post Road
Wayland, MA 01778 US
Other 510(k) Applications for this Company
Contact
Sharon Timberlake
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
12/13/2018
Decision Date
02/01/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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