Manufacturer
Cook IncorporatedRhapsody H-30 Holmium Laser System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K172325
- Device name
- Rhapsody H-30 Holmium Laser System
- Company
- Cook Incorporated
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-08-01
- Decision date
- 2017-10-26
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
1—
—
Not ingested
K172325 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K172325 as a predicate