← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K253251

# Leaseir MHR Xcell  (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) (K253251)

_Leaseir Technologies, Slu · GEX · May 4, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253251

## Device Facts

- **Applicant:** Leaseir Technologies, Slu
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** May 4, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253251](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253251)

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