Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → OLP — Over-The-Counter Powered Light Based Laser For Acne # OLP · Over-The-Counter Powered Light Based Laser For Acne _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP ## Overview - **Product Code:** OLP - **Device Name:** Over-The-Counter Powered Light Based Laser For Acne - **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K253878.md) | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Mar 4, 2026 | SESE | | [K251843](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K251843.md) | Erchonia EVRL | Erchonia Corporation | Sep 12, 2025 | SESE | | [K242068](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K242068.md) | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | Apr 4, 2025 | SESE | | [K243555](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K243555.md) | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. | Feb 5, 2025 | SESE | | [K232656](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K232656.md) | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | Nov 14, 2023 | SESE | | [K230490](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K230490.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K230720.md) | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | Jul 3, 2023 | SESE | | [K213056](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K213056.md) | LED Facial Mask | Shenzhen Osto Technology Company Limited | Jul 7, 2022 | SESE | | [K220729](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K220729.md) | The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | Jun 9, 2022 | SESE | | [K213039](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K213039.md) | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | May 25, 2022 | SESE | | [K210545](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K210545.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K214103.md) | Shani Darden LED light therapy mask | Harpar Grace International | Mar 22, 2022 | SESE | | [K210968](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K210968.md) | reVive Light Therapy Essentials | Led Technologies, Inc. | Dec 21, 2021 | SESE | | [K213184](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K213184.md) | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | Nov 23, 2021 | SESE | | [K203214](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K203214.md) | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. | Jul 22, 2021 | SESE | | [K203271](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K203271.md) | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | Jul 21, 2021 | SESE | | [K210948](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K210948.md) | Omnilux CLEAR | Globalmed Technologies | Jun 24, 2021 | SESE | | [K202055](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K202055.md) | Looper (Model: ZX-579S) | Heat IN A Click, LLC | Apr 16, 2021 | SESE | | [K192295](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K192295.md) | PDT-FACE | Beijing Adss Development Co., Ltd. | May 1, 2020 | SESE | | [K183708](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K183708.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com