Manufacturer
Dawell Medical, LLCLithoblast Single Use Holmium Laser Fibers
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
- K250776
- Device name
- Lithoblast Single Use Holmium Laser Fibers
- Company
- Dawell Medical, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-03-14
- Decision date
- 2025-10-14
- Submission type
- Traditional
- Technology type
- Er:YAG(AI inferred)
- Clinical applications
- Surgical cuttingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The LithoBlast Single-Use Holmium Laser Fiber is indicated for use in surgical specialties in which a compatible Ho:YAG laser system has received regulatory clearance. LithoBlast surgical fiber optic laser delivery devices are intended for use with any open source cleared surgical laser with an SMA 905 connector.
Intended Use
The LithoBlast Single-Use Holmium Laser Fiber is indicated for use in surgical specialties in which a compatible Ho:YAG laser system has received regulatory clearance. LithoBlast surgical fiber optic laser delivery devices are intended for use with any open source cleared surgical laser with an SMA 905 connector.
Device Description
The LithoBlast Single-Use Holmium Laser Fibers are single use surgical fiberoptic laser delivery devices that transmit laser energy in a forward direction. The devices include a SMA 905 connector at the proximal end. The laser fibers are compatible with Ho:YAG laser systems. There are four (4) fiber core diameters: 272 Series (272 µm), 365 Series (365 µm), 550 Series (550 µm), and 940 Series (940 µm). The laser fibers in the LithoBlast family are 300cm long. All have a 10 mm straight cut flat cleaved distal end. All include a stress booth and an ABS over nut extension sleeve (type A=straight and narrow; type B=indented with finger grips; type C=finger grips protrude) to enable the operator's firm grip. The SMA-905 connector attaches at the proximal end of the device.
Summary parsed at:2026-06-01 05:22:35 UTC
Predicate devices
1Laser Peripherals, LLC Family of Bare Laser Fibers
K250776 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 K250776 as a predicate