# K243701: AuroLase® System

- Pathway: 510(k) (Traditional)
- Applicant: Nanospectra Biosciences, Inc.
- Decided: Jul 2, 2025 after 215 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: 10 generations back to K943450 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051996: Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30, Diomed, Ltd. (2005) Summary page 5.

## Indications for use
The AuroLase System is intended for use in delivering up to 9 Watts of continuous wave radiation to a flexible optical fiber for use in ablation, incision, excision, coagulation and vaporization of soft tissues in open and endoscopic surgical procedures including in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedic.

Source page: https://510kreport.com/device/K243701
Methodology: https://510kreport.com/methodology