K253251
- 510(k) number
- K253251
- Device name
- Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)
- Applicant
- Leaseir Technologies, Slu ES
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-05-04
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K253251.pdf
Official FDA record: K253251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.