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) → ONG — Powered Laser Surgical Instrument With Microbeam\Fractional Output # ONG · Powered Laser Surgical Instrument With Microbeam\Fractional Output _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG ## Overview - **Product Code:** ONG - **Device Name:** Powered Laser Surgical Instrument With Microbeam\Fractional Output - **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 35) Showing 20 most recent of 35 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252155](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K252155.md) | AVAVA™ Skin Treatment System | AVAVA, Inc. | Oct 20, 2025 | SESE | | [K244060](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K244060.md) | eCO2 3D | Lutronic Corporation | Jul 31, 2025 | SESE | | [K251031](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K251031.md) | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | Jul 2, 2025 | SESE | | [K250402](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K250402.md) | AVAVA™ Skin Treatment System | AVAVA, Inc. | Apr 14, 2025 | SESE | | [K233550](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K233550.md) | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | Jan 2, 2024 | SESE | | [K223871](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K223871.md) | Miria Skin Treatment System | AVAVA, Inc. | Jun 22, 2023 | SESE | | [K221268](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K221268.md) | SR-1 Skin Treatment System | AVAVA, Inc. | Nov 21, 2022 | SESE | | [K221770](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K221770.md) | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | Oct 13, 2022 | SESE | | [K213332](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K213332.md) | Multifrax Laser System | Paradigm Medical Corporation | Jun 3, 2022 | SESE | | [K202884](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K202884.md) | SR-1 Skin Treatment System | AVAVA, Inc. | Apr 13, 2021 | SESE | | [K192350](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K192350.md) | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics , Ltd. | Apr 30, 2020 | SESE | | [K182498](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K182498.md) | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | Nov 30, 2018 | SESE | | [K180036](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K180036.md) | SMAXEL CO2 Surgical Laser System | Ids, Ltd. | Feb 2, 2018 | SESE | | [K162398](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K162398.md) | CO2 Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | Jul 6, 2017 | SESE | | [K141868](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K141868.md) | TRIA FANP | Tria Beauty, Inc. | Dec 30, 2014 | SESE | | [K141046](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K141046.md) | MIDI-SRS | Srmc Co., Ltd. | Dec 24, 2014 | SESE | | [K130459](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K130459.md) | TRIA FAN SYSTEM | Tria Beauty, Inc. | Oct 25, 2013 | SESE | | [K131903](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K131903.md) | EQUINOX CO2 LASER | Eclipse Aesthetics, LLC | Sep 19, 2013 | SESE | | [K130028](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K130028.md) | RESURFX 1565NM LASER MODULE | Lumenis, Ltd. | Sep 3, 2013 | SESE | | [K110333](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K110333.md) | NATURALASE CO2 LASER SYSTEM | Focus Medical, LLC | Apr 12, 2012 | SESE | ## Top Applicants - AVAVA, Inc. — 5 clearances - Palomar Medical Products, Inc. — 3 clearances - Solta Medical, Inc. — 3 clearances - Lutronic Corporation — 2 clearances - Palomar Medical Technologies, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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