# K230506: PureLift Pro Edition

- Pathway: 510(k) (Special)
- Applicant: Xtreem Pulse
- Decided: Jun 21, 2023 after 117 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011935 (2001). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221443: PureLift Pro Plus, Xtreem Pulse, LLC (2022) Summary page 4.
- K933804: Lectron II Conductive Gel/Cadwell Electrode Gel, Cadwell Laboratories, Inc. (1994) Summary page 4.

## Most influential descendants
- K252146: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (2025), 1 descendant of its own
- K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (2026), 0 descendants of its own

## Indications for use
Intended for facial stimulation and indicated for over-the-counter cosmetic use.

Source page: https://510kreport.com/device/K230506
Methodology: https://510kreport.com/methodology