Eon
FDA 510(k) K222226 · Dominion Aesthetic Technologies, Inc.
510(k) numberK222226
Submission
- Device name
- Eon
- Applicant
- Dominion Aesthetic Technologies, Inc.
Winter Park, FL, US - Received
- July 25, 2022
- Decision date
- February 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKT – Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5400
- Specialty
- General, Plastic Surgery
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
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|---|---|---|---|
| K240658 | 1060nm laser body slimming machinePKT · Traditional | Hebei JT Medical Co., Ltd. | 05/13/2024SE |
| K233962 | ReBorn (1050nm)PKT · Traditional | Lightfective , Ltd. | 04/16/2024SE |
| K231971 | Deka Physiq 360PKT · Traditional | El.En S.P.A. | 09/26/2023SE |
| K231131 | Diode Laser Body Sculpture SystemsPKT · Traditional | Shanghai Bele Medical Technology Co.,Ltd | 06/22/2023SE |
| K222265 | DiosculptPKT · Traditional | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 09/23/2022SE |
| K211681 | EonPKT · Traditional | Dominion Aesthetic Technologies, Inc. | 03/30/2022SE |
| K212331 | BodySculpPKT · Traditional | Rohrer Aesthetics, LLC | 11/09/2021SE |
| K211402 | Powersculp laser lipolysis systemPKT · Traditional | Lotuxs Medtech (Suzhou) Co., Ltd. | 07/30/2021SE |
| K192970 | SlimusPKT · Traditional | Hironic Co., Ltd. | 12/01/2020SE |
| K201731 | Diode Laser Body Sculpture SystemPKT · Traditional | Shanghai Apolo Medical Technology Co., Ltd. | 09/10/2020SE |
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Questions and answers
When was Eon cleared by the FDA?
Eon (K222226) received a 510(k) decision of Substantially Equivalent on February 17, 2023, 207 days after the submission was received.
What is the product code of K222226?
The FDA product code is PKT – Laser For Disruption Of Adipocyte Cells For Aesthetic Use, a Class II (moderate risk) device regulated under 21 CFR 878.5400.