# K192272: Wolf445nm

- Pathway: 510(k) (Traditional)
- Applicant: A.R.C Laser GmbH
- Decided: Mar 17, 2020 after 208 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: 1 generation back to K951034 (1995). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951034: Aura Laser System, Laserscope (1995) Summary page 4.

## Most influential descendants
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K221712: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) (2022), 1 descendant of its own
- K243683: Deka Bluebeam (2025), 0 descendants of its own
- K232885: Dawn Diode Laser System (2024), 0 descendants of its own
- K220531: Fox 810, Fox 980 (2022), 0 descendants of its own

## Indications for use
The Wolf 445nm is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Source page: https://510kreport.com/device/K192272
Methodology: https://510kreport.com/methodology