OLP — Over-The-Counter Powered Light Based Laser For Acne Class II
Classification Details
- Product Code
- OLP
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253878 | shenzhen kaiyan medical equipment co | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | March 4, 2026 |
| K251843 | erchonia corporation | Erchonia EVRL | September 12, 2025 |
| K242068 | ningbo dechang electrical machinery made co | LED Light Therapy Mask (RT01) | April 4, 2025 |
| K243555 | shenzhen eyco technology co | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, | February 5, 2025 |
| K232656 | premier north america | BLU TOTALE (Model: ENEOB852) | November 14, 2023 |
| K230490 | dongguan hunter electronic technology co | PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-N | October 27, 2023 |
| K230720 | light tree ventures europe | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | July 3, 2023 |
| K213056 | shenzhen osto technology company limited | LED Facial Mask | July 7, 2022 |
| K220729 | luminance medical ventures | The Luminance RED Acne Device | June 9, 2022 |
| K213039 | li-tek electronics technology c0 | Micro-current facial cold and hot service (model: TPML-100) | May 25, 2022 |
| K210545 | marci beauty | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light hea | May 20, 2022 |
| K214103 | harpar grace international | Shani Darden LED light therapy mask | March 22, 2022 |
| K210968 | led technologies | reVive Light Therapy Essentials | December 21, 2021 |
| K213184 | mz skin | MZ Skin LightMAX Supercharged LED Mask 2.0 | November 23, 2021 |
| K203214 | shenzhen kaiyan medical co | DemarkQ WOW, DemarkQ POP | July 22, 2021 |
| K203271 | shenzhen kaiyan medical co | Aduro light therapy Handheld | July 21, 2021 |
| K210948 | globalmed technologies | Omnilux CLEAR | June 24, 2021 |
| K202055 | heat in a click | Looper (Model: ZX-579S) | April 16, 2021 |
| K192295 | beijing adss development co | PDT-FACE | May 1, 2020 |
| K183708 | medtek skincare | Poly Clear | September 17, 2019 |