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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
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
Jimena De La Vega 140 1g Cp
Gijon,  ES 33203
Applicant Contact Sergio Camacho Santiago
Correspondent
Paladin Medical, Inc.
415 Valley View Trl.
Houlton,  WI  54082
Correspondent Contact Sergio C Santiago
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/29/2025
Decision Date 05/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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