FDA 510(k) Application Details - K202361

Device Classification Name

  More FDA Info for this Device
510(K) Number K202361
Device Name UltraSlim Digital, UltraSmooth Digital
Applicant Ward Photonics LLC
1980 N Atlantic Avenue
Cocoa Beach, FL 32931 US
Other 510(k) Applications for this Company
Contact Terry Ward
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 08/19/2020
Decision Date 12/18/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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