ONF · Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | ONF |
|---|---|
| Device Name | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | Sep 4, 2025 | SESE |
| K231952 | MEDILIGHT | Medicreations, LLC | Sep 3, 2025 | SESE |
| K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | Jul 3, 2025 | SESE |
| K250281 | DEKA LOTUS | El.En S.P.A. | Feb 26, 2025 | SESE |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. | Nov 14, 2024 | SESE |
| K240314 | MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | Aug 21, 2024 | SESE |
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | May 17, 2024 | SESE |
| K233473 | DEKA LOTUS | El.En S.P.A. | May 16, 2024 | SESE |
| K233307 | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | Mar 15, 2024 | SESE |
| K232708 | Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. | Dec 1, 2023 | SESE |
| K232192 | Venus Versa PRO System | Venus Concept, Inc. | Sep 11, 2023 | SESE |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | Aug 9, 2023 | SESE |
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | Apr 21, 2023 | SESE |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | Feb 18, 2023 | SESE |
| K220794 | 10PL | Tentech Co. , Ltd. | Nov 10, 2022 | SESE |
| K221214 | 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 | Intense Pulsed Light Equipment | Beijing Globalipl Development Co., Ltd. | Aug 12, 2022 | SESE |
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | Mar 8, 2022 | SESE |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products , Ltd. | Dec 2, 2021 | SESE |
| K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | Oct 4, 2021 | SESE |
Top Applicants
- Shaser, Inc. — 9 clearances
- Beijing Adss Development Co., Ltd. — 2 clearances
- Beijing Globalipl Development Co., Ltd. — 2 clearances
- El.En S.P.A. — 2 clearances
- Shangdong Huamei Technology Co., Ltd. — 2 clearances
