FDA UDI
In Commercial Distribution
🇺🇸 United States
Leaseir Technologies SLU
DI: 08437019546014
·
Model: Leaseir MHR Xcell
·
LEASEIR TECHNOLOGIES SOCIEDAD LIMITADA.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Leaseir Technologies SLU
- Primary DI
- 08437019546014
- Version / Model
- Leaseir MHR Xcell
- Company Name
- LEASEIR TECHNOLOGIES SOCIEDAD LIMITADA.
- Labeler DUNS
- 463721653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-21
- Public Version
- 1
- Public Version Date
- 2024-02-29
- Public Version Status
- New
- Public Device Record Key
- b7fb2e78-3583-4cdf-b7f2-be628f7cf487
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 Leaseir MHR Xcell consists of a main console and two interchangeable applicators (Dual and Quad) that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58786 | Dermatological diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437019546014 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K214049 | 000 |