| Date Initiated by Firm | December 15, 2025 |
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| Date Posted | January 16, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1130-2026 |
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| Recall Event ID |
98176 |
| 510(K)Number | K214049 |
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| Product Classification |
Powered laser surgical instrument - Product Code GEX
|
| Product | Brand Name: LEASEIR
Product Name: LEASEIR MHR XCELL
Model/Catalog Number: MHR 110-b
Software Version: 1.5.0.0
Product 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 13.515 mm and 14.525.5 mm. 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.
Component: NO |
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| Code Information |
Lot Code: Device#1:
Model: Leaseir MHR Xcell
Serial Number: C10016, C10017
UDI-DI: 08437019546076
|
| FEI Number |
3023344928
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Recalling Firm/
Manufacturer |
LEASEIR TECHNOLOGIES SLU
Calle Marconi G 246
Gijon Spain
|
| For Additional Information Contact | ELAINE DUNCAN
1-715-5496035 |
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Manufacturer Reason
for Recall | The console label for affected devices is missing the "DANGER" symbol. |
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FDA Determined
Cause 2 | Error in labeling |
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| Action | On October 29, 2025, the firm notified the single US consignee. This was followed up by an email on December 18, 2025. The consignee was given information regarding the field corrective action for the console labels and missing danger symbol.
The consignee was provided with replacement labels and instructions for the correction of both affected units. |
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| Quantity in Commerce | 2 |
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| Distribution | US Nationwide distribution in the states of Austin, Texas. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = GEX
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