FDA 510(k) Application Details - K243780

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K243780
Device Name	Powered Laser Surgical Instrument
Applicant	Laseroptek Co., Ltd. #203 & #204 Hyundai I valley, 31, Galmachi-ro 244 beon-gil Jungwon-gu Seongnam-si 13212 KR Other 510(k) Applications for this Company
Contact	Chu Hong 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	12/09/2024
Decision Date	02/07/2025
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