# K162053: PhotonBlade

- Pathway: 510(k) (Traditional)
- Applicant: Invuity, Inc.
- Decided: Sep 15, 2016 after 52 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933157 (1994). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device, Peak Surgical, Inc. (2010) Summary page 4.
- K944363: Model PBD Esu Pencil, Coral Medical, Inc. (1994) Summary page 4.

## Most influential descendants
- K191583: PhotonBlade with Smoke Evacuation (2020), 0 descendants of its own

## Recalls of this device
- Jun 12, 2017 · Class II · Z-2778-2017: A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.

## Indications for use
The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures.

Source page: https://510kreport.com/device/K162053
Methodology: https://510kreport.com/methodology