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510(k) Data Aggregation
K Number
K222364Device Name
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
Manufacturer
Date Cleared
2022-11-16
(104 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Xtrallux, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xtrallux Alpha, Super Plus, Turbo Pro, and Extreme RX are intended to treat Androgenetic Alopecia (AGA) and promote hair growth in males who have Norwood-Hamilton Classifications of hair loss and, females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
Device Description
The Xtrallux devices are non-invasive, low level laser therapy (LLT) devices containing red, visible light diode lasers operating at 650 nm wavelength. The maximum power output of each diode is 5 mW. The diodes are configured within a cap, enclosed between the outer shell and inner liner. They deliver non-thermal energy to hair follicles via photostimulation of the scalp and are intended to stimulate hair growth. Xtrallux has developed four models: Xtrallux Alpha, Xtrallux Super Plus, Xtrallux Turbo Pro, Xtrallux Extreme RX.
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