Identifiers
- 510(k) Number
- K241102 FDA 510(k)
- FDA Product Code
- OHS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Luna 4 plus is a cleansing device that combines clinical-grade anti-aging treatments with advanced skincare technology. It is designed to remove 99% of impurities from the skin while providing additional benefits such as red LED light therapy and targeted microcurrent massage to tone facial muscles and reduce the appearance of fine lines and sagging.
The device is supplied as a single-use item and is intended for at-home use. It operates using T-sonic technology and features near-infrared heating. Luna 4 plus is regulated as a Class II medical device and has received FDA 510(k) clearance. Proper storage and handling instructions should be followed to maintain device performance and safety.
Frequently asked questions
What is the Luna 4 plus used for?
The Luna 4 plus is a cleansing device that removes 99% of impurities and provides anti-aging benefits through red LED light therapy and microcurrent massage to tone facial muscles.
Is the Luna 4 plus a single-use device?
No, the Luna 4 plus is not a single-use device; it is intended for at-home use and is supplied as a reusable item.
What technology does the Luna 4 plus use?
The device uses T-sonic technology for cleansing and features near-infrared heating for additional skin benefits.
What is the regulatory status of the Luna 4 plus?
The Luna 4 plus is a Class II medical device that has received FDA 510(k) clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Amazon Luna: Gaming-Service, FOREO LUNA™ 4 plus | Red LED Cleansing & Microcurrent, Amazon Luna: Gaming Service, FOREO Luna 4 Plus Facial Cleansing Brush - Near Infrared & Red ... - Amazon, LUNA™ 4 plus Manual | FOREO
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241102 | Class II | Active |
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Manufacturer
- Manufacturer
- Foreo, Inc.
Sources (1)
- FDA 510(k) K241102 24 fields · synced Sep 24, 2026