Manufacturer
Leaseir Technologies, SluLeaseir MHR Xcell
Country / Region:Spain (ES)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K214049
- Device name
- Leaseir MHR Xcell
- Company
- Leaseir Technologies, Slu
- 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
Predicate devices
1elysion-pro
K214049 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
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