Chrysalis Intelligence · Sponsors · Leaseir Technologies, Slu

Leaseir Technologies, Slu

Gijón, ES · 2 510(k) clearances · 1 recalls

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Total clearances
2
2022-06-02 → 2026-05-04
Last 12 months
1
Product codes
1
Most recent
2026-05-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEX Powered Laser Surgical Instrument Class II General, Plastic Surgery 2 2026-05-04
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2025-12-15
DateSeverityStatusRecall # ProductCodeReason
2025-12-15 Class II Completed Z-1130-2026 Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Produc… — The console label for affected devices is missing the "DANGER" symbol.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2026-05-04 K253251 Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) GEX Class II General, Plastic Surgery
2022-06-02 K214049 Leaseir MHR Xcell GEX Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence