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) → ONF — Powered Light Based Non-Laser Surgical Instrument With Thermal Effect # ONF · Powered Light Based Non-Laser Surgical Instrument With Thermal Effect _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF ## Overview - **Product Code:** ONF - **Device Name:** Powered Light Based Non-Laser Surgical Instrument With Thermal Effect - **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) - **3rd-party reviewable:** yes ## 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 73) Showing 20 most recent of 73 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251545](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K251545.md) | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | Sep 4, 2025 | SESE | | [K231952](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K231952.md) | MEDILIGHT | Medicreations, LLC | Sep 3, 2025 | SESE | | [K243123](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K243123.md) | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | Jul 3, 2025 | SESE | | [K250281](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K250281.md) | DEKA LOTUS | El.En S.P.A. | Feb 26, 2025 | SESE | | [K242440](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K242440.md) | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. | Nov 14, 2024 | SESE | | [K240314](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K240314.md) | MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | Aug 21, 2024 | SESE | | [K240482](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K240482.md) | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | May 17, 2024 | SESE | | [K233473](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K233473.md) | DEKA LOTUS | El.En S.P.A. | May 16, 2024 | SESE | | [K233307](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K233307.md) | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | Mar 15, 2024 | SESE | | [K232708](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K232708.md) | Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. | Dec 1, 2023 | SESE | | [K232192](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K232192.md) | Venus Versa PRO System | Venus Concept, Inc. | Sep 11, 2023 | SESE | | [K231394](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K231394.md) | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | Aug 9, 2023 | SESE | | [K230816](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K230816.md) | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | Apr 21, 2023 | SESE | | [K220214](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K220214.md) | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | Feb 18, 2023 | SESE | | [K220794](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K220794.md) | 10PL | Tentech Co. , Ltd. | Nov 10, 2022 | SESE | | [K221214](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K221214.md) | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 | Shenzhen Ionka Medical Technology Co., Ltd. | Sep 21, 2022 | SESE | | [K220385](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K220385.md) | Intense Pulsed Light Equipment | Beijing Globalipl Development Co., Ltd. | Aug 12, 2022 | SESE | | [K213558](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K213558.md) | IPL Hair Removal Device | Ulike Co., Ltd. | Mar 8, 2022 | SESE | | [K212907](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K212907.md) | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products , Ltd. | Dec 2, 2021 | SESE | | [K211368](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K211368.md) | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | Oct 4, 2021 | SESE | ## Top Applicants - Shaser, Inc. — 9 clearances - Venus Concept , Ltd. — 2 clearances - Syneron Beauty , Ltd. — 2 clearances - Smedtrum Medical Technology Co., Ltd. — 2 clearances - Shangdong Huamei Technology Co., Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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