FDA 510(k) Application Details - K241358

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K241358
Device Name	Powered Laser Surgical Instrument
Applicant	Sun Pharmaceutical Industries, Inc. 29 Dunham Rd. Billerica, MA 01821 US Other 510(k) Applications for this Company
Contact	Scott Lundahl 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	05/14/2024
Decision Date	06/13/2024
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