The following data is part of a premarket notification filed by Xtrallux, Llc with the FDA for Xtrallux Alpha (xa136r-usa), Xtrallux Super Plus (xs276r-usa/xs276l-usa), Xtrallux Turbo Pro (xp316r-usa), Xtrallux Extreme Rx (xr352r-usa).
| Device ID | K222364 |
| 510k Number | K222364 |
| Device Name: | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) |
| Classification | Laser, Comb, Hair |
| Applicant | Xtrallux, LLC 7260 NW 58th Street Miami, FL 33166 |
| Contact | Carlos Piña |
| Correspondent | Freeman Anike RQM+ 2251 San Diego Avenue Suite B-257 San Diego, CA 92110 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-04 |
| Decision Date | 2022-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007783449 | K222364 | 000 |
| 00860007783432 | K222364 | 000 |
| 00860007783425 | K222364 | 000 |
| 00860007783418 | K222364 | 000 |
| 00860007783401 | K222364 | 000 |