Cleared Special

K070659 - BIOLUCENT APPLICATOR KIT

K070659 is an FDA 510(k) clearance for BIOLUCENT APPLICATOR KIT, manufactured by Biolucent, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Special 510(k) pathway after a 26-day FDA review.

K070659 · Biolucent, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
26d
Days
Class 2
Risk

K070659 is an FDA 510(k) clearance for the BIOLUCENT APPLICATOR KIT. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Biolucent, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 4, 2007 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biolucent, Inc. devices

FDA 510(k) Submission Details - K070659

510(k) Number K070659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 09, 2007
Decision Date April 04, 2007
Days to Decision 26 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 136
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K070659.
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
K071381 · Varian Medical Systems · Jul 2007
VARISOURCE IX HDR AFTERLOADER
K071467 · Varian Medical Systems, Inc. · Jul 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229 · Senorx, Inc. · May 2007
VARIAN ESOPHAGUS BOUGIE APPLICATOR
K063815 · Varian Medical Systems · Mar 2007
HDR CT COMPATIBLE SPLIT RING APPLICATOR
K063382 · Mick Radio-Nuclear Instruments, Inc. · Dec 2006
CT COMPATIBLE F/S/D APPLICATORS
K063381 · Mick Radio-Nuclear Instruments, Inc. · Dec 2006