OLP
- Product code
- OLP
- Device name
- Over-The-Counter Powered Light Based Laser For Acne
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4810
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 51
FDA classification definition
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.
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253878 | 2026-03-04 | Shenzhen Kaiyan Medical Equipment Co., | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | FDA |
| K251843 | 2025-09-12 | Erchonia Corporation | Erchonia EVRL | |
| K242068 | 2025-04-04 | Ningbo Dechang Electrical Machinery Ma | LED Light Therapy Mask (RT01) | |
| K243555 | 2025-02-05 | Shenzhen Eyco Technology Co., Ltd. | LED light therapy mask (E43, E32, E49B, E49C, E100B, | |
| K232656 | 2023-11-14 | Premier North America, Inc. | BLU TOTALE (Model: ENEOB852) | |
| K230490 | 2023-10-27 | Dongguan Hunter Electronic Technology | PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, | FDA |
Official FDA classification page: OLP
Classification and pathway per current FDA publications. Data from openFDA (CC0).