Biolucent Applicator Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K070659 ↗

FDA Product Code

JAQ

Device Class

Class II

Regulation

21 CFR Part 892.5700

Advisory Committee

Radiology

FDA Decision

SESU

• Curay Custom Seed Array

  Class II

  FDA 510(k) K053595 Active Cleared 28 Feb 2006

• Biolucent Mammography Cushion

  Class II

  FDA 510(k) K003795 Active Cleared 14 Feb 2001

• Biolucent Applicator Kit

  Class II

  FDA 510(k) K062830 Active Cleared 20 Oct 2006

• Biolucent Applicator, Model Rta-Xx

  Class II

  FDA 510(k) K061241 Active Cleared 28 Jul 2006

• Mammopad Radiolucent Cushion

  Class I

  FDA 510(k) K062141 Active Cleared 13 Sep 2006

• What is the Biolucent Applicator Kit used for?

  The Biolucent Applicator Kit is used as an accessory to commercially available remote afterloading equipment during brachytherapy procedures, providing multiple lumens that serve as pathways for delivering a prescribed radiation dose to the treatment area.

• How is the Biolucent Applicator Kit supplied and intended for use?

  The Biolucent Applicator Kit is supplied as a kit and is intended for use in radiology settings, specifically as an accessory to remote afterloading systems in brachytherapy treatments.

• Is the Biolucent Applicator Kit a single-use or reusable device?

  The device data does not specify whether the Biolucent Applicator Kit is single-use or reusable; therefore, no determination about reusability can be made from the provided information.

• What regulatory pathway was used for the Biolucent Applicator Kit?

  The Biolucent Applicator Kit received FDA 510(k) clearance, as indicated in the AUTHORIZATIONS field and confirmed by the k_number K070659 and decision_date of 2007-04-04.

• What is the device classification and product code for the Biolucent Applicator Kit?

  The Biolucent Applicator Kit is classified as a Class II medical device with product code JAQ, as stated in the openfda field and confirmed by the product_code and regulation_number 892.5700.