FDA 510(k) Application Details - K243014

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K243014
Device Name	Laser, Ophthalmic
Applicant	EyeQ Inc. 8740 Technology Way Suite 200 Reno, NV 89521 US Other 510(k) Applications for this Company
Contact	Gary Mocnik 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	09/27/2024
Decision Date	06/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review