Data / Medical devices / United States / Xtrallux, LLC
Xtrallux, LLC: FDA-registered device maker in Miami, FL, United States, 2 510(k) clearances
Xtrallux, LLC is registered with the FDA (registration 3025432379) in Miami, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 23, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025432379
- Address
- 7260 NW 58 Street, Miami, FL, United States, 33166
- Owner or operator
- Xtrallux, LLC (10086800)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 13, 2022
- Registered through
- 2026
- Brand names listed
- Xtrallux Alpha, Xtrallux Extreme RX, Xtrallux Lasercomb Alpha, Xtrallux Super Plus, Xtrallux Turbo Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2023 | K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | OAP | Substantially Equivalent | Hubei Yjt Technology Co.,Ltd | accessdata.fda.gov |
| November 16, 2022 | K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) | OAP | Substantially Equivalent | Xtrallux, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.