# K202953: Aurolase Therapy, Laser Delivery Device (LDD)

- Pathway: 510(k) (Traditional)
- Applicant: Nanospectra Biosciences, Inc.
- Decided: Oct 3, 2022 after 733 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: 2 generations back to K963081 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053087: Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System, Biotex, Inc. (2006) Summary page 4.

## Indications for use
The Aurolase Therapy, Laser Delivery Device is a fiber-optical laser delivery device to be used with a compatible 810nm laser device for laser-based applications and procedures that are cleared for the compatible laser.

Source page: https://510kreport.com/device/K202953
Methodology: https://510kreport.com/methodology