FDA 510(k) Application Details - K222395

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K222395
Device Name	Laser, Ophthalmic
Applicant	Ellex Medical Pty Ltd 3-4 Second Avenue Mawson Lakes Adelaide AU Other 510(k) Applications for this Company
Contact	Rashmi Pillay Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2022
Decision Date	11/02/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review