FDA 510(k) Application Details - K250402

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K250402
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	Avava Inc 275 2nd Ave 3rd Floor Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Richard Bankowski Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2025
Decision Date	04/14/2025
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