510(k) K261865
K261865 is an FDA 510(k) premarket notification submitted by Stabilix, LLC for the device "AerFrame Alignment Laser Box (LBV2)". The FDA issued a decision of Substantially Equivalent on September 16, 2026. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Stabilix, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2026
- Date Received
- June 4, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type