FDA.report

510(k) K250776

Device
Lithoblast Single Use Holmium Laser Fibers
Applicant
Dawell Medical, LLC
510(k) number
K250776
Product code
GEX
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-14
Date received
2025-03-14
Regulation
878.4810
Classification name
Powered Laser Surgical Instrument
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Carlos Irias
Address
18505 SW 104th Ave. Unit 25 Miami FL US 33157 33157

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00850069558574Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLC2026-03-10
00850069558673Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558109Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558840Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558703Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558710Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558727Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558734Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558741Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558758Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558765Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558772Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558789Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558796Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02
00850069558802Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLC2026-03-02

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