LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
FDA 510(k) K230720 · Light Tree Ventures Europe B.V.
510(k) numberK230720
Submission
- Device name
- LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
- Applicant
- Light Tree Ventures Europe B.V.
Hague, NL - Received
- March 16, 2023
- Decision date
- July 3, 2023
- 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.
Other 510(k)s with product code OLP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)OLP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 03/04/2026SE |
| K251843 | Erchonia EVRLOLP · Traditional | Erchonia Corporation | 09/12/2025SE |
| 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 |
| 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 |
| K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…OLP · Traditional | Marci Beauty, Inc. | 05/20/2022SE |
More from Marci Beauty, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260415 | myLEDmask 2 (MJ-144)OHS · Traditional | 05/12/2026SE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional | 12/24/2025SE |
| K223893 | Infrared Heat (Model: E0221)OHS · Traditional | 05/16/2023SE |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)OAP · Traditional | 04/28/2023SE |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023)OHS · Traditional | 04/28/2023SE |
| K230336 | CurrentBody Skin Led Hair Regrowth(Model: MZ-07)OAP · Traditional | 04/05/2023SE |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)OHS · Traditional | 03/15/2023SE |
| K223642 | LED Lip Perfector, model: ZC-05ILY · Traditional | 03/09/2023SE |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)OHS · Traditional | 12/20/2022SE |
| K221444 | LED Eye Perfector, model: EY-36A, EY-36BOHS · Traditional | 12/08/2022SE |
Questions and answers
When was LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 cleared by the FDA?
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 (K230720) received a 510(k) decision of Substantially Equivalent on July 3, 2023, 109 days after the submission was received.
What is the product code of K230720?
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.