OLP · Over-The-Counter Powered Light Based Laser For Acne
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | OLP |
|---|---|
| Device Name | Over-The-Counter Powered Light Based Laser For Acne |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 51)
Showing 20 most recent of 51 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Mar 4, 2026 | SESE |
| K251843 | Erchonia EVRL | Erchonia Corporation | Sep 12, 2025 | SESE |
| K242068 | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | Apr 4, 2025 | SESE |
| K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. | Feb 5, 2025 | SESE |
| K232656 | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | Nov 14, 2023 | SESE |
| K230490 | PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT | Dongguan Hunter Electronic Technology Co., Ltd. | Oct 27, 2023 | SESE |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | Jul 3, 2023 | SESE |
| K213056 | LED Facial Mask | Shenzhen Osto Technology Company Limited | Jul 7, 2022 | SESE |
| K220729 | The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | Jun 9, 2022 | SESE |
| K213039 | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | May 25, 2022 | SESE |
| K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine | Marci Beauty, Inc. | May 20, 2022 | SESE |
| K214103 | Shani Darden LED light therapy mask | Harpar Grace International | Mar 22, 2022 | SESE |
| K210968 | reVive Light Therapy Essentials | Led Technologies, Inc. | Dec 21, 2021 | SESE |
| K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | Nov 23, 2021 | SESE |
| K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. | Jul 22, 2021 | SESE |
| K203271 | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | Jul 21, 2021 | SESE |
| K210948 | Omnilux CLEAR | Globalmed Technologies | Jun 24, 2021 | SESE |
| K202055 | Looper (Model: ZX-579S) | Heat IN A Click, LLC | Apr 16, 2021 | SESE |
| K192295 | PDT-FACE | Beijing Adss Development Co., Ltd. | May 1, 2020 | SESE |
| K183708 | Poly Clear | Medtek Skincare, LLC | Sep 17, 2019 | SESE |
Top Applicants
- Nutra Luxe MD, LLC — 4 clearances
- Led Technologies, Inc. — 3 clearances
- Silver Bay, LLC — 2 clearances
- Shenzhen Kaiyan Medical CO , Ltd. — 2 clearances
- Led Intellectual Properties, LLC — 2 clearances
