510(k) K193602

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source by Lv Liberty Vision Corporation — Product Code KXK

K193602 is an FDA 510(k) premarket notification submitted by Lv Liberty Vision Corporation for the device "LV Liberty Vision Model 1 90Yttrium Brachytherapy Source". The FDA issued a decision of Substantially Equivalent on May 29, 2020. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
December 23, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type