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

Country / region:Spain (ES)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

Company

Spain (ES)

Product code

GEX

21 CFR 878.4810

Predicate devices

Cited in this 510(k)

Cited as predicate

Device details

FDA 510(k) registration fields

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)
Company: Leaseir Technologies, Slu
Country / region: Spain(ES)
Product code: GEX
Device class: Class 2
Regulation number: 21 CFR 878.4810
Date received: 2025-09-29
Decision date: 2026-05-04
Submission type: Traditional
Technology type: Diode(AI inferred)
Clinical applications: Hair removal
Primary application: Hair removal
Classification source: AI classified

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