FDA 510(k) Application Details - K152357

Device Classification Name	Lens, Guide, Intraocular   More FDA Info for this Device
510(K) Number	K152357
Device Name	Lens, Guide, Intraocular
Applicant	STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016 US Other 510(k) Applications for this Company
Contact	Jack Coggan Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	KYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2015
Decision Date	10/30/2015
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