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) → OHS — Light Based Over The Counter Wrinkle Reduction # OHS · Light Based Over The Counter Wrinkle Reduction _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS ## Overview - **Product Code:** OHS - **Device Name:** Light Based Over The Counter Wrinkle Reduction - **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 148) Showing 20 most recent of 148 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260202](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K260202.md) | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | Mar 23, 2026 | SESE | | [K260511](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K260511.md) | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | Mar 16, 2026 | SESE | | [K254079](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K254079.md) | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | Mar 16, 2026 | SESE | | [K253874](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253874.md) | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | Mar 3, 2026 | SESE | | [K253683](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253683.md) | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo, Inc. | Feb 20, 2026 | SESE | | [K254007](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K254007.md) | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. | Feb 12, 2026 | SESE | | [K253833](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253833.md) | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | Jan 30, 2026 | SESE | | [K252603](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K252603.md) | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jan 28, 2026 | SESE | | [K253712](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253712.md) | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co., Ltd. | Jan 23, 2026 | SESE | | [K253400](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253400.md) | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | Dec 24, 2025 | SESE | | [K253279](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253279.md) | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | Dec 24, 2025 | SESE | | [K253135](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253135.md) | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. | Dec 23, 2025 | SESE | | [K253086](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253086.md) | LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co., Ltd. | Dec 19, 2025 | SESE | | [K253054](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253054.md) | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | Dec 19, 2025 | SESE | | [K252983](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K252983.md) | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. | Dec 17, 2025 | SESE | | [K252994](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K252994.md) | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) | Guangdong Ace-Tec Co., Ltd. | Dec 8, 2025 | SESE | | [K252142](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K252142.md) | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | Dec 5, 2025 | SESE | | [K253073](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K253073.md) | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. | Nov 19, 2025 | SESE | | [K252642](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K252642.md) | Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | Nov 19, 2025 | SESE | | [K252308](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS/K252308.md) | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | Nov 13, 2025 | SESE | ## Top Applicants - Shenzhen Kaiyan Medical Equipment Co., Ltd. — 14 clearances - Led Technologies, Inc. — 9 clearances - Light Tree Ventures Europe B.V. — 6 clearances - Led Intellectual Properties, LLC — 5 clearances - Foreo, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHS) **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