# K241102: Luna 4 plus

- Pathway: 510(k) (Traditional)
- Applicant: Foreo, Inc.
- Decided: Aug 20, 2024 after 120 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 164 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162652: Smart Photon Micro-current Device, Model: EP-300, Li-Tek Electronic Technology Corporation (2017) Summary page 5.
- K212155: TheraFace LED, Theragun, Inc. (2021) Summary page 5.
- K201906: Trinity ELE Plus and Trinity ELE Plus Pro, Carol Cole Company Dba Nuface (2021) Summary page 5.

## Most influential descendants
- K243423: LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (2025), 3 descendants of its own
- K253712: LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (2026), 1 descendant of its own
- K260767: Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) (2026), 0 descendants of its own
- K261407: XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) (2026), 0 descendants of its own
- K250880: Led Light Mask (A093) (2025), 0 descendants of its own

## Indications for use
Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage. Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

Source page: https://510kreport.com/device/K241102
Methodology: https://510kreport.com/methodology