FDA 510(k) Application Details - K231950

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K231950
Device Name	Powered Laser Surgical Instrument
Applicant	Medicreations LLC 6370 Annie Oakley Dr. Las Vegas, NV 89120 US Other 510(k) Applications for this Company
Contact	Anthony Hardy 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	06/30/2023
Decision Date	08/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review