Leaseir MHR Xcell

Leaseir Technologies, Slu

Country / region:Spain (ES)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Spain (ES)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K214049
Device name
Leaseir MHR Xcell
Country / region
Spain(ES)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-12-27
Decision date
2022-06-02
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalAcne treatment
Primary application
Hair removal
Classification source
AI classified

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 I-VI)

Intended 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 I-VI).

Device Description

The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5×15 mm² and 14.5×25.5 mm². Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed.

Summary parsed at:2026-06-01 05:39:20 UTC

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