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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 K250776
Device Name Lithoblast Single Use Holmium Laser Fibers
Applicant
Dawell Medical, LLC
18505 SW 104th Ave.
Unit 25
Miami,  FL  33157
Applicant Contact Carlos Irias
Correspondent
TAG3 Engineering
1161 Sawgrass Corporate Pkwy.
Sunrise,  FL  33323
Correspondent Contact Diane Horwitz
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/14/2025
Decision Date 10/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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