FDA 510(k) Application Details - K131783

Device Classification Name Case, Contact Lens

  More FDA Info for this Device
510(K) Number K131783
Device Name Case, Contact Lens
Applicant VIOPTI LTD
POLAROID BLDG, VALE OF LEVEN INDUSTRIAL ESTATE
DUMBARTON G82 3PW GB
Other 510(k) Applications for this Company
Contact EDWIN LINDSAY
Other 510(k) Applications for this Contact
Regulation Number 886.5928

  More FDA Info for this Regulation Number
Classification Product Code LRX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/17/2013
Decision Date 02/21/2014
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact