Leaseir Technologies SLU

GUDID 08437019546014

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

LEASEIR TECHNOLOGIES SOCIEDAD LIMITADA.

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• Primary Device ID: 08437019546014
• NIH Device Record Key: b7fb2e78-3583-4cdf-b7f2-be628f7cf487
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leaseir Technologies SLU
• Version Model Number: Leaseir MHR Xcell
• Company DUNS: 463721653
• Company Name: LEASEIR TECHNOLOGIES SOCIEDAD LIMITADA.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437019546014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214049

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-29
• Device Publish Date: 2024-02-21