LightStim for Acne/ LightStim for Acne Mini
FDA 510(k) K142246 · Led Intellectual Properties, LLC
510(k) numberK142246
Submission
- Device name
- LightStim for Acne/ LightStim for Acne Mini
- Applicant
- Led Intellectual Properties, LLC
Irvine, CA, US - Received
- August 14, 2014
- Decision date
- January 29, 2015
- 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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| K242068 | LED Light Therapy Mask (RT01)OLP · Traditional | Ningbo Dechang Electrical Machinery Made Co.,Ltd | 04/04/2025SE |
| K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)OLP · Traditional | Shenzhen Eyco Technology Co., Ltd. | 02/05/2025SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038)OHS · Traditional | 07/31/2026SE |
| K212771 | LightStim ElipsaOHS · Traditional | 01/26/2022SE |
| K153399 | LightStim Professional LED BedILY · Traditional | 07/05/2016SE |
| K151336 | LightStim Professional 2-Panel LightOHS · Traditional | 10/23/2015SE |
| K151333 | LightStim for Pain LED BeltILY · Traditional | 08/21/2015SE |
| K150098 | LightStim Professional 2-Panel LightOHS · Traditional | 04/09/2015SE |
| K131461 | Lightstim for Acne/ Lightstim for Acne MiniOLP · Traditional | 01/06/2014SE |
| K120775 | Light for WrinklesOHS · Traditional | 06/04/2012SE |
| K101190 | Lightstim Anti-Wrinkle OTC Model Aal OTCOHS · Traditional | 07/01/2010SE |
| K092800 | Anti-Wrinkle (Aging) Light, Model AalONE · Traditional | 02/04/2010SE |
Questions and answers
When was LightStim for Acne/ LightStim for Acne Mini cleared by the FDA?
LightStim for Acne/ LightStim for Acne Mini (K142246) received a 510(k) decision of Substantially Equivalent on January 29, 2015, 168 days after the submission was received.
What is the product code of K142246?
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.