Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The MH01 laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. It is indicated in medical specialties including, but not limited to: • Urology • Gastroenterology • Arthroscopy • Neurosurgery • Pulmonary • Gynecology • ENT • Dermatology • Plastic Surgery • General Surgery
The MH01 laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. It is indicated in medical specialties including, but not limited to: Urology, Gastroenterology, Arthroscopy, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.
The modified device MH01 is a tower version of the already cleared device Litho DK30 (K141403). It differs from Litho DK30 in the housing of components (tower frame instead of desktop) and a modified graphic user interface. Both devices are Pulsed Holmium:YAG lasers with a maximum output power of 30 W @ 2.1 µm, sharing the same architecture and laser source. The modifications include a new mechanical structure housing the internal components and a reviewed GUI.
Summary parsed at:2026-06-01 06:11:33 UTC
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K152220 references 1 predicate/reference device
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