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US
Last updated September 17, 2026
What FOREO INC makes
Foreo Inc manufactures home-use personal care devices, including battery-powered electric toothbrushes, transcutaneous neuromuscular electrical stimulation (TENS) systems for physical therapy, and phototherapy lamps for skin treatments. Their portfolio also includes hair removal units using intense pulsed light (IPL) technology, as well as laser devices for hair growth stimulation and radio-frequency/multi-modality skin and body contouring systems. Devices are designed for at-home use and target oral hygiene, muscle stimulation, skin rejuvenation, and hair-related treatments.
Foreo Inc’s products are classified under FDA’s Class I and Class II regulatory categories, with most devices listed in the FDA’s UDI (Unique Device Identification) database. The company is based in the United States, where its devices are subject to FDA compliance requirements for safety and performance before market authorisation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Foreo Inc manufacture?
Foreo Inc specializes in home-use personal care devices that span multiple categories. Their portfolio includes battery-powered electric toothbrushes for oral hygiene, transcutaneous neuromuscular electrical stimulation (TENS) systems for physical therapy, and phototherapy lamps designed for skin treatments like hair removal (using intense pulsed light) and hair growth stimulation (via laser technology). They also produce radio-frequency and multi-modality systems for skin and body contouring, all intended for at-home use.
Where is Foreo Inc based, and how does that affect its devices?
Foreo Inc is based in the United States, which means its devices must comply with FDA regulations before being authorized for market sale. The FDA classifies Foreo’s products as either Class I (generally low-risk devices) or Class II (devices requiring special controls to ensure safety and performance), ensuring they meet strict standards for safety and efficacy before reaching consumers.
Are Foreo’s devices listed in any regulatory registries, and why does that matter?
Yes, Foreo’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and monitor medical devices in the U.S. market, ensuring transparency and traceability. Listing in the UDI system is required for Class II devices and voluntary for Class I, but it aids in regulatory oversight, recall management, and patient safety by providing standardized identification for each product.
How are Foreo’s devices classified by the FDA, and what does that classification mean?
Foreo’s devices fall under FDA’s Class I and Class II classifications. Class I devices, like some of their basic electric toothbrushes, typically pose minimal risk and are subject to general controls (e.g., labeling, manufacturing practices). Class II devices, such as their phototherapy lamps or TENS systems, require additional regulatory oversight due to moderate risk, including performance standards or post-market surveillance to ensure safety and effectiveness.
What kinds of treatments or conditions do Foreo’s devices target?
Foreo’s devices address a range of personal care and wellness needs. Their electric toothbrushes focus on oral hygiene, while TENS systems target muscle pain or physical therapy needs. Phototherapy lamps (IPL and laser-based) are designed for hair removal or hair growth stimulation, and their radio-frequency/multi-modality systems aim to improve skin texture, tone, or body contouring. All are intended for at-home use without requiring professional supervision.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1525 E Pama Lane, Las Vegas, NV, 89119
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3012104022
- DUNS Number
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Catalogue (123)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ISSA 4 Baby | Kiwi Green | FDA UDI | Class I | Active |
| Issa™ Compact | 7350071076606 | FDA UDI | Class I | Active |
| ISSA™ mini | WILD STRAWBERRY | FDA UDI | Class I | Active |
| ISSA™ play | SUMMER SKY | FDA UDI | Class I | Active |
| ISSA™ kids | MERRY BERRY SHARK | FDA UDI | Class I | Active |
| Issa™ 2 | COBALT BLUE | FDA UDI | Class I | Active |
| ISSA™ play | PEARL PINK | FDA UDI | Class I | Active |
| BEAR 2 go | Pistachio | FDA UDI | Class II | Active |
| ISSA™ mikro | PEARL PINK | FDA UDI | Class I | Active |
| ISSA™ Pro Set | COBALT BLUE | FDA UDI | Class I | Active |
| Issa™ 2 | COOL BLACK | FDA UDI | Class I | Active |
| Espada 2 | Fuchsia | FDA UDI | Class II | Active |
| ISSA™ Hybrid | LAVENDER | FDA UDI | Class I | Active |
| PEACH 2, PEACH 2 Duo, PEACH 2 go | K231977 | FDA 510(k) | Class II | Active |
| Faq 101 | K222012 | FDA 510(k) | Class II | Active |
| ESPADA Acne-Clearing Blue Light Pen | K162450 | FDA 510(k) | Class II | Active |
| FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | K253683 | FDA 510(k) | Class II | Active |
| Faq™ (302) | K242747 | FDA 510(k) | Class II | Active |
| Faq™ 201, Faq™ 202 | K240378 | FDA 510(k) | Class II | Active |
| BEAR and BEAR mini | K200803 | FDA 510(k) | Class II | Active |
| Luna 4 plus | K241102 | FDA 510(k) | Class II | Active |
| Faq™ (102) | K240616 | FDA 510(k) | Class II | Active |
| BEAR 2 Body | K232242 | FDA 510(k) | Class II | Active |
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