FDA.reportPublic FDA data

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
No

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

Other 510(k) Records For Product Code GEX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260690LumiGlam Laser System (SHE-LSP601-3)Beijing Sano Laser S&T Development Co.,Ltd2026-06-04
K260489LASEmaR 1500Eufoton S.R.L.2026-05-29
K260138LUNE PureHygieneEnamel Pure2026-05-29
K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.2026-05-21
K260100MOSES Raydar™Boston Scientific Corporation2026-05-18
K261214PICO SHINING (PICO-K; PICOFY)Speclipse, Inc.2026-05-11
K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.2026-05-07
K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.2026-05-04
K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)Leaseir Technologies, Slu2026-05-04
K261094YellowStarAsclepion Laser Technologies GmbH2026-04-29
K253765VANISH PRODdc Technologies, Inc.2026-04-22
K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.2026-04-20
K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.2026-04-15
K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.2026-04-09
K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.2026-03-31