FDA 510(k) Application Details - K213592

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K213592
Device Name	Laser, Ophthalmic
Applicant	Iridex Corporation 1212 Terra Bella Ave. Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Bill Hyatt 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	11/12/2021
Decision Date	03/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review