The following data is part of a premarket notification filed by Xstrahl Ltd. with the FDA for Photoelectric Therapy System.
| Device ID | K172080 |
| 510k Number | K172080 |
| Device Name: | Photoelectric Therapy System |
| Classification | System, Therapeutic, X-ray |
| Applicant | Xstrahl Ltd. Unit 2 Maybrook Industrial Estate, Maybrook Road, Walsall Wood Brownhills, GB Ws8 7dg |
| Contact | Andrew Mullen |
| Correspondent | Andrew Mullen Xstrahl Ltd. Unit 2 Maybrook Industrial Estate, Maybrook Road, Walsall Wood Brownhills, GB Ws8 7dg |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-10 |
| Decision Date | 2017-09-29 |
| Summary: | summary |