510(k) K230611
K230611 is an FDA 510(k) premarket notification submitted by Xstrahl, Ltd. for the device "X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)". The FDA issued a decision of Substantially Equivalent on July 13, 2023. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Xstrahl, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2023
- Date Received
- March 6, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Therapeutic, X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type