# K241832: Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Aesthetics, Inc.
- Decided: Feb 13, 2025 after 233 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: 20 generations back to K943450 (1995). 289 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 291 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192545: Potenza, Jeisys Medical Incorporated (2020) Summary page 5.
- K160469: AGNES, Gowoonsesang Cosmetics Co., Ltd. (2017) Summary page 5.
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500, Capenergy Medical S.L. (2023) Summary page 5.

## Most influential descendants
- K254290: ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (2026), 0 descendants of its own

## Indications for use
The Unicorn+ RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The RF System is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.

Source page: https://510kreport.com/device/K241832
Methodology: https://510kreport.com/methodology