# K191583: PhotonBlade with Smoke Evacuation

- Pathway: 510(k) (Traditional)
- Applicant: Invuity, Inc.
- Decided: Mar 6, 2020 after 266 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933157 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162053: PhotonBlade, Invuity, Inc. (2016) Summary page 4.

## Indications for use
The PhotonBlade® with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Source page: https://510kreport.com/device/K191583
Methodology: https://510kreport.com/methodology