FDA 510(k) Application Details - K222500

Device Classification Name Lenses, Soft Contact, Daily Wear

  More FDA Info for this Device
510(K) Number K222500
Device Name Lenses, Soft Contact, Daily Wear
Applicant Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 US
Other 510(k) Applications for this Company
Contact Sherri Lakota
Other 510(k) Applications for this Contact
Regulation Number 886.5925

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

  More FDA Info for this Product Code
Date Received 08/18/2022
Decision Date 09/15/2022
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



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