Faq (102)
FDA 510(k) K240616 · Foreo, Inc.
510(k) numberK240616
Submission
- Device name
- Faq (102)
- Applicant
- Foreo, Inc.
Las Vegas, NV, US - Received
- March 5, 2024
- Decision date
- July 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PAY – Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4420
- Specialty
- General, Plastic Surgery
An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250341 | Sensilift Pro (ST300XXYYZZZ)PAY · Traditional | El Global Trade, Ltd. | 01/06/2026SE |
| K242227 | Geneo X ElitePAY · Traditional | Pollogen, Ltd. | 10/12/2025SE |
| K233766 | Geneo X ElitePAY · Special | Pollogen, Ltd. | 05/07/2024SE |
| K232424 | CurrentBody Skin RFPAY · Traditional | El Global Trade, Ltd. | 03/06/2024SE |
| K230013 | Silk'n Titan AllwaysPAY · Traditional | Silk'N Beauty , Ltd. | 08/30/2023SE |
| K220322 | Pollogen STOP U Model UXV DevicePAY · Traditional | Pollogen, Ltd. | 05/04/2023SE |
| K222012 | Faq 101PAY · Traditional | Foreo, Inc. | 04/05/2023SE |
| K203665 | STOP U Model UXV DevicePAY · Special | Pollogen, Ltd. | 02/25/2021SE |
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA)PAY · Traditional | Pollogen, Ltd. | 06/19/2019SE |
| K170499 | sensiLiftPAY · Traditional | El Global Trade, Ltd. | 06/15/2017SE |
More from El Global Trade, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253683 | FAQ (LED Panel); FAQ (Dual LED Panel)OHS · Traditional | 02/20/2026SE |
| K242747 | Faq (302)OAP · Traditional | 12/11/2024SE |
| K241102 | Luna 4 plusOHS · Traditional | 08/20/2024SE |
| K232242 | BEAR 2 BodyNFO · Traditional | 05/13/2024SE |
| K240378 | Faq 201, Faq 202OHS · Traditional | 04/19/2024SE |
| K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 goOHT · Traditional | 09/25/2023SE |
| K222012 | Faq 101PAY · Traditional | 04/05/2023SE |
| K200803 | BEAR and BEAR miniNFO · Traditional | 07/31/2020SE |
| K162450 | ESPADA Acne-Clearing Blue Light PenOLP · Traditional | 11/30/2016SE |
Questions and answers
When was Faq (102) cleared by the FDA?
Faq (102) (K240616) received a 510(k) decision of Substantially Equivalent on July 15, 2024, 132 days after the submission was received.
What is the product code of K240616?
The FDA product code is PAY – Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, a Class II (moderate risk) device regulated under 21 CFR 878.4420.