Class Class II
Luna 4 plus (K241102)
Description
Luna 4 plus by Foreo, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241102
Clearance Date2024-08-20
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241102
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Luna 4 plus (K241102) cites 3 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212155 | TheraFace LED | Theragun, Inc. | 2021 |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | Carol Cole Company Dba Nuface | 2021 |
| K162652 | Smart Photon Micro-current Device, Model: EP-300 | Li-Tek Electronic Technology Corpor... | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; ... | Kam Yuen Plastic Products , Ltd. | 2026 |
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, R... | Shenzhen Rainbow Technology Co., Ltd. | 2025 |
Trace the full predicate network for K241102
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.