Sapphire, Elevare Sapphire
FDA 510(k) K172555 · Omm Imports, Inc. D/B/A Zero Gravity
510(k) numberK172555
Submission
- Device name
- Sapphire, Elevare Sapphire
- Applicant
- Omm Imports, Inc. D/B/A Zero Gravity
Doral, FL, US - Received
- August 24, 2017
- Decision date
- May 1, 2018
- 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 |
| K230490 | PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…OLP · Traditional | Dongguan Hunter Electronic Technology Co., Ltd. | 10/27/2023SE |
| 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 |
More from Li-Tek Electronics Technology C0., Ltd.
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| K183329 | Laser Hair TherapyOAP · Traditional | 01/16/2019SE |
Questions and answers
When was Sapphire, Elevare Sapphire cleared by the FDA?
Sapphire, Elevare Sapphire (K172555) received a 510(k) decision of Substantially Equivalent on May 1, 2018, 250 days after the submission was received.
What is the product code of K172555?
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.