# K253251: Leaseir MHR Xcell  (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)

- Pathway: 510(k) (Traditional)
- Applicant: Leaseir Technologies, Slu
- Decided: May 4, 2026 after 217 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K943450 (1995). 579 ancestors in all.
No later device cites it as a predicate yet.
0 of 580 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214049: Leaseir MHR Xcell, Leaseir Technologies, Slu (2022) Summary page 5.
- K241656: Eneka Selectif, Termosalud (2024) Summary page 5.
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application, Alma Lasers, Inc. (2011) Summary page 5.

## Indications for use
Indications for use for the Leaseir MHR Xcell diode laser system with 810nm applicator includes: Hair Removal with Statis and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9, and 12 months after the completion of a treatment regime Treatment of Pseudofolliculitis barbae (PFB) Use on all skin types (Fitzpatrick I-VI) Treatment of benign vascular lesions Treatment of benign pigmented lesions Indications for use for the Leaseir MHR Xcell diode laser system with 810-1060nm applicator includes: Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-rowing when measured at 6,9, and 12 months after the completion of a treatment regime Treatment of Pseudofolliculitis barbae (PFB) Use on all skin types (Fitzpatrick I-VI

Source page: https://510kreport.com/device/K253251
Methodology: https://510kreport.com/methodology