Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
FDA 510(k) K210545 · Marci Beauty, Inc.
510(k) numberK210545
Submission
- Device name
- Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
- Applicant
- Marci Beauty, Inc.
Las Vegas, NV, US - Received
- February 25, 2021
- Decision date
- May 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLP – Over-The-Counter Powered Light Based Laser For Acne
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
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| K232656 | BLU TOTALE (Model: ENEOB852)OLP · Traditional | Premier North America, Inc. | 11/14/2023SE |
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| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001OLP · Traditional | Light Tree Ventures Europe B.V. | 07/03/2023SE |
| K213056 | LED Facial MaskOLP · Traditional | Shenzhen Osto Technology Company Limited | 07/07/2022SE |
| K220729 | The Luminance RED Acne DeviceOLP · Traditional | Luminance Medical Ventures, Inc. | 06/09/2022SE |
| K213039 | Micro-current facial cold and hot service (model: TPML-100)OLP · Traditional | Li-Tek Electronics Technology C0., Ltd. | 05/25/2022SE |
Questions and answers
When was Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine cleared by the FDA?
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine (K210545) received a 510(k) decision of Substantially Equivalent on May 20, 2022, 449 days after the submission was received.
What is the product code of K210545?
The FDA product code is OLP – Over-The-Counter Powered Light Based Laser For Acne, a Class II (moderate risk) device regulated under 21 CFR 878.4810.