Liberty Vision Model 1 90 Yttrium Brachytherapy Source

No FDA recalls found in the data synced 5 Oct 2026.

Full name

LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source

510(k) Number

K163572 ↗

FDA Product Code

KXK

Device Class

Class II

Regulation

21 CFR Part 892.5730

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

  Class II

  FDA 510(k) K193602 Active Cleared 29 May 2020

• What is the LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source used for?

  This device is designed for episcleral radiation therapy, delivering beta radiation from yttrium-90 to treat ocular tumors and benign growths. The localized radiation targets the eye’s surface, minimizing exposure to surrounding tissues. It is intended for use within a manual brachytherapy system in clinical settings where precise, controlled radiation delivery is required.

• How is the LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source supplied and is it reusable?

  The device is supplied as a single-use, sealed source, meaning each unit is intended for one application only. This design ensures sterility and safety, as reuse could compromise integrity and radiation safety protocols. The sealed construction also prevents contamination and ensures consistent activity levels for each procedure.

• What safety measures must be followed when storing and handling this device?

  Due to its radioactive nature, storage and handling must strictly adhere to radiation safety protocols. The sealed source must be stored in a secure, shielded location to prevent unauthorized access or accidental exposure. Clinicians must follow manufacturer instructions for proper containment, disposal, and monitoring of radiation levels. Training in radiation safety is mandatory for all personnel involved in its use.

• Is this device regulated by the FDA, and what class does it fall under?

  Yes, the LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source is regulated under FDA 510(k) clearance (K163572) and classified as a Class II medical device. This classification reflects its role as a radionuclide source requiring special controls to ensure safety and effectiveness in radiation therapy applications. The device adheres to regulatory standards for brachytherapy sources.

• What distinguishes the Model 1 from other yttrium-90 brachytherapy sources?

  The Model 1 is specifically designed for episcleral application, targeting radiation directly to the eye’s surface for ocular tumors or benign growths. Its single-use, sealed construction ensures consistency in activity levels and sterility, which differentiates it from reusable or non-sealed sources. The device is also FDA-cleared under K163572, validating its equivalence to predicate devices in this specialized application.