Avologi ENEO
FDA 510(k) K181659 · Premier North America, Inc.
510(k) numberK181659
Submission
- Device name
- Avologi ENEO
- Applicant
- Premier North America, Inc.
Fort Lauderdale, FL, US - Received
- June 25, 2018
- Decision date
- July 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OHS – Light Based Over The Counter Wrinkle Reduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Other 510(k)s with product code OHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…OHS · Traditional | Kam Yuen Plastic Products , Ltd. | 08/31/2026SE |
| K261602 | Eye Recovery Pro (PH-e03)OHS · Traditional | Shenzhen Goodwind Technology Development Co., Ltd. | 08/10/2026SE |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)OHS · Traditional | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 08/07/2026SE |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…OHS · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 08/04/2026SE |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756)OHS · Traditional | Duplex International Trading Limited | 08/04/2026SE |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038)OHS · Traditional | Led Intellectual Properties, LLC | 07/31/2026SE |
| K260598 | 5 Wavelength LED Facemask (TN2508)OHS · Traditional | iSMART Developments, Ltd. | 07/24/2026SE |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…OHS · Traditional | Dongguan Miqiang Technology Co., Ltd. | 07/15/2026SE |
| K261473 | ChromixOHS · Traditional | Termosalud S.L. | 07/01/2026SE |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)OHS · Traditional | Guangdong Newdermo Biotech Co., Ltd. | 06/29/2026SE |
More from Guangdong Newdermo Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233862 | Nuna Lux (NUNL528)OHS · Traditional | 03/01/2024SE |
| K232656 | BLU TOTALE (Model: ENEOB852)OLP · Traditional | 11/14/2023SE |
| K220735 | Avologi Gel Primer (Model: Av25)GYB · Traditional | 09/15/2023SE |
| K214100 | LuminiceNFO · Traditional | 02/24/2022SE |
| K213841 | ENEO TOTALE (Model: ENEOT947)OHS · Special | 01/06/2022SE |
Questions and answers
When was Avologi ENEO cleared by the FDA?
Avologi ENEO (K181659) received a 510(k) decision of Substantially Equivalent on July 26, 2018, 31 days after the submission was received.
What is the product code of K181659?
The FDA product code is OHS – Light Based Over The Counter Wrinkle Reduction, a Class II (moderate risk) device regulated under 21 CFR 878.4810.