FDA 510(k) Application Details - K210300

Device Classification Name	Accessories, Solution, Ultrasonic Cleaners For Lenses   More FDA Info for this Device
510(K) Number	K210300
Device Name	Accessories, Solution, Ultrasonic Cleaners For Lenses
Applicant	VueSonic, LLC 1234 Washington Ave., #205 Miami Beach, FL 33139 US Other 510(k) Applications for this Company
Contact	Sheri Ker Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LYL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2021
Decision Date	04/01/2021
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