510(k) K172080
K172080 is an FDA 510(k) premarket notification submitted by Xstrahl, Ltd. for the device "Photoelectric Therapy System". The FDA issued a decision of Substantially Equivalent on September 29, 2017. 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
- September 29, 2017
- Date Received
- July 10, 2017
- 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