FDA 510(k) Application Details - K201909

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K201909
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	RxSight, Inc. 100 Colombia 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	886.1385   More FDA Info for this Regulation Number
Classification Product Code	HJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2020
Decision Date	09/10/2020
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