FDA 510(k) Application Details - K180402

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K180402
Device Name	Laser, Ophthalmic
Applicant	Topcon Medical Laser Systems, Inc. 606 Enterprise Ct. Livermore, CA 94550 US Other 510(k) Applications for this Company
Contact	Sweta Srivastava 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	02/14/2018
Decision Date	05/25/2018
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