AerFrame Alignment Laser Box (LBV2)— 510(k) K261865
Substantially EquivalentStabilix, LLC
FDA 510(k) clearance K261865 for AerFrame Alignment Laser Box (LBV2), Substantially Equivalent on 2026-09-16. Applicant: Stabilix, LLC. Device class: 2.
Summary
Stabilix, LLC filed the AerFrame Alignment Laser Box (LBV2) under product code IYE (Accelerator, Linear, Medical). The record gives the model number and nothing more about the device.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Stabilix filed from Dallas, Texas. The decision came 104 calendar days after receipt (June 4 to September 16, 2026).
Clearance details
- Applicant
- Stabilix, LLC
- Product code
- Product code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code IYE
view allMore clearances from Stabilix, LLC
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.