# K250776: Lithoblast Single Use Holmium Laser Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Dawell Medical, LLC
- Decided: Oct 14, 2025 after 214 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 402 ancestors in all.
No later device cites it as a predicate yet.
0 of 403 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers, Laser Peripherals, LLC (2017) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K250776
Methodology: https://510kreport.com/methodology