FDA 510(k) Application Details - K192926

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K192926
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	RxSight, Inc. 100 Columbia Aliso Viejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Maureen O'Connell Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	MSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2019
Decision Date	01/17/2020
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