# K203299: CellFX System

- Pathway: 510(k) (Traditional)
- Applicant: Pulse Biosciences, Inc.
- Decided: Feb 2, 2021 after 85 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: 17 generations back to K943450 (1995). 225 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K102461: Fractora, Invasix, Ltd. (2011) Summary page 4.

## Most influential descendants
- K211444: CellFX System (2021), 3 descendants of its own
- 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/K203299
Methodology: https://510kreport.com/methodology