Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications.
The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications.
Laser Wavelength 2100 nm. Maximum Output 30 W. Repetition Rate 5 to 20 Hz. Visible Aiming Beam Variable intensity <3 mW. Minimum Energy 0.5 J at 5 Hz. Maximum Energy 3.5 J at 5 Hz. Input Voltage 115 & 230 V (full power). Detects a resistor embedded within the fiber to identify the size of the attached fiber and limit the laser energy to the fiber's maximum allowable power output. Communicates with a printed circuit board (two-way communication) embedded within the laser fiber to display extra information onscreen, or recording use information for the laser system and the fiber such as power setting, number of pulses, and error codes. Max Flash-lamp Voltage 700 V. Blast Shield User accessible. Water Reservoir Plastic. Filter De-ionized cartridge & strainer. Enclosure Metal with cabinet & flat top. Control Panel Rotatable. Water Pump Fixed with slightly different orientation. Firmware 1.5 version 1.6 version.
Summary parsed at:2026-06-01 06:00:39 UTC
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K172325 references 1 predicate/reference device
No later 510(k)s cite this device yet
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