# K214049: Leaseir MHR Xcell

- Pathway: 510(k) (Traditional)
- Applicant: Leaseir Technologies, Slu
- Decided: Jun 2, 2022 after 157 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 528 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 530 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193367: elysion-pro, High Technology Products S.L.U (2020) Summary page 4.

## Most influential descendants
- K253251: Leaseir MHR Xcell  (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) (2026), 0 descendants of its own

## Recalls of this device
- Dec 15, 2025 · Class II · Z-1130-2026: The console label for affected devices is missing the "DANGER" symbol.

## Indications for use
Indications for use for Leaseir MHR Xcell diode laser hair removal system with 810nm 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-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 1-VI)

Source page: https://510kreport.com/device/K214049
Methodology: https://510kreport.com/methodology