# K211444: CellFX System

- Pathway: 510(k) (Traditional)
- Applicant: Pulse Biosciences, Inc.
- Decided: Aug 25, 2021 after 107 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: 18 generations back to K943450 (1995). 226 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203299: CellFX System, Pulse Biosciences, Inc. (2021) Summary page 4.

## Most influential descendants
- K213674: CellFX System (2022), 0 descendants of its own
- K222075: CellFX System (2022), 0 descendants of its own
- K221671: CellFX® System (2022), 0 descendants of its own

## Indications for use
The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K211444
Methodology: https://510kreport.com/methodology