RF-Relief
FDA 510(k) K181095 · El Global Trade, Ltd.
510(k) numberK181095
Submission
- Device name
- RF-Relief
- Applicant
- El Global Trade, Ltd.
Netanya, IL - Received
- April 26, 2018
- Decision date
- July 24, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
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|---|---|---|---|
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| K253261 | Apollo Quattro (APQ-10M)PBX · Traditional | Weero Co., Ltd. | 03/13/2026SE |
| K252888 | NeoSculpt PlusPBX · Traditional | S&M Medical Co., Ltd. | 03/09/2026SE |
| K250734 | OptiLUV DevicePBX · Traditional | Pollogen, Ltd. | 09/10/2025SE |
| K250916 | WinForth (LM-E470KA)PBX · Traditional | Shenzhen Leaflife Technology Co., Ltd. | 08/14/2025SE |
| K243716 | Zionic Pro Max (Radiofrequency)PBX · Traditional | Termosalud S.L. | 05/28/2025SE |
| K241733 | Hebe (NP0000763)PBX · Traditional | Novasonix Technology S.L. | 04/16/2025SE |
| K243055 | Préime DermaFacial Collagen+PBX · Traditional | EMA Aesthetics , Ltd. | 04/15/2025SE |
| K242175 | XOD Diathermia Radiofrequency DevicePBX · Traditional | Xod, Inc. | 02/27/2025SE |
More from Xod, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252621 | DeepSkin (DEP100)NFO · Traditional | 05/08/2026SE |
| K250341 | Sensilift Pro (ST300XXYYZZZ)PAY · Traditional | 01/06/2026SE |
| K250384 | IPL400OHT · Traditional | 05/23/2025SE |
| K232424 | CurrentBody Skin RFPAY · Traditional | 03/06/2024SE |
| K183260 | Sensilight Pro / Pistol IPLOHT · Traditional | 03/18/2019SE |
| K172181 | micro IPLOHT · Traditional | 10/13/2017SE |
| K170637 | sensiFirmPBX · Traditional | 07/14/2017SE |
| K170499 | sensiLiftPAY · Traditional | 06/15/2017SE |
| K161089 | sensiLight MiniOHT · Traditional | 07/08/2016SE |
| K140381 | Sensilight/ Sensilight PlusOHT · Traditional | 08/08/2014SE |
Questions and answers
When was RF-Relief cleared by the FDA?
RF-Relief (K181095) received a 510(k) decision of Substantially Equivalent on July 24, 2018, 89 days after the submission was received.
What is the product code of K181095?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.