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FDA 510(k)

AerFrame™ Alignment Laser Box (LBV2)

K-Number: K261865 · 2026-09-16

ApplicantStabilix, LLC
Decision Date2026-09-16
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AerFrame™ Alignment Laser Box (LBV2) is the device name listed in this FDA 510(k) record. The listed applicant is Stabilix, LLC. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261865. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AerFrame™ Alignment Laser Box (LBV2)?

AerFrame™ Alignment Laser Box (LBV2) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Stabilix, LLC. The 510(k) number is K261865.

When did AerFrame™ Alignment Laser Box (LBV2) receive FDA 510(k) clearance?

AerFrame™ Alignment Laser Box (LBV2) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261865.

Who is the listed applicant for AerFrame™ Alignment Laser Box (LBV2)?

The FDA 510(k) record lists Stabilix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AerFrame™ Alignment Laser Box (LBV2)?

The FDA product code for AerFrame™ Alignment Laser Box (LBV2) is IYE.

Other records listing Stabilix, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260792AerFrame Patient Immobilization System (AFPIS)

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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