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The Tracker / September 2026 / K261865

510(k) cleared

AerFrame Alignment Laser Box (LBV2)

Stabilix, LLC · Sep 16, 2026 · K261865

FDA cleared the AerFrame Alignment Laser Box (LBV2) from Stabilix, LLC on Sep 16, 2026 under K261865, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 4, 2026. The decision came 104 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stabilix, LLC has one other decision in the tracker over the last 12 months: K260792 (AerFrame Patient Immobilization System (AFPIS)).

Questions & Answers

What did FDA clear under K261865?

K261865 is the FDA 510(k) for AerFrame Alignment Laser Box (LBV2), submitted by Stabilix, LLC. FDA's decision date was Sep 16, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the AerFrame Alignment Laser Box (LBV2)?

Stabilix, LLC, based in Dallas, TX, is the applicant of record for K261865.

How long did the K261865 review take?

FDA received the submission on Jun 4, 2026 and issued its decision on Sep 16, 2026, 104 days later.

← All decisions in September 2026

Sources