ONF · Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Device class

Class II

Regulation 878.4810

Total clearances

2020-03-05 → 2026-06-12

Last 12 months

Unique sponsors

Definition

What is Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4810

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Beijing Globalipl Development Co., Ltd.	2	0	2022-08-12
Smedtrum Medical Technology Co., Ltd.	2	0	2024-05-17
El.En S.P.A.	2	0	2025-02-26
Nanjing Bestview Laser S&T Co., Ltd.	1	0	2024-11-14
Sanhe LEFIS Electronics Co., Ltd.	1	1	2026-06-12
Shanghai Apolo Medical Technology Co., Ltd.	1	0	2020-05-15
Medusa (Guangxi)Medical Devices Co., Ltd.	1	0	2025-07-03
Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.	1	0	2021-05-21
Luvo Medical Technologies, Inc.	1	0	2020-03-05
Tentech Co. , Ltd.	1	0	2022-11-10
Shanghai Omni Laser Skinology Co., Ltd.	1	0	2023-02-18
Shenzhen Accompany Technology Co., Ltd.	1	0	2021-09-24
Guangzhou Ciellulu Photoelectric Technology Co., Ltd.	1	0	2024-08-21
Micowey Medical Equipment (Guangxi) Co., Ltd.	1	1	2025-09-04
E-Swin	1	0	2020-06-11
Hebei Zhemai Technology Co., Ltd.	1	0	2023-12-01
Venus Concept, Inc.	1	0	2023-09-11
Ulike Co., Ltd.	1	0	2022-03-08
Shenzhen Ionka Medical Technology Co., Ltd.	1	0	2022-09-21
Beijing Adss Development Co., Ltd.	1	0	2024-03-15
Shenzhen Mywin Technology Co., Ltd.	1	0	2021-10-04
Shangdong Huamei Technology Co., Ltd.	1	0	2023-04-21
Kam Yuen Plastic Products , Ltd.	1	0	2021-12-02
Medicreations, LLC	1	1	2025-09-03

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
17999	CPT	—	Medium	Unlisted procedure, skin, mucous membrane and subcutaneous tissue for IPL/thermal light-based use
96999	CPT	—	Low	Unlisted special dermatologic procedure

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-12	K261204	Sanhe LEFIS Electronics Co., Ltd.	Intense Pulsed Light Therapy Device
2025-09-04	K251545	Micowey Medical Equipment (Guangxi) Co., Ltd.	Intense Pulsed Light Therapy Device (MMABM-1)
2025-09-03	K231952	Medicreations, LLC	MEDILIGHT
2025-07-03	K243123	Medusa (Guangxi)Medical Devices Co., Ltd.	IPL Treatment Device (MDSQMC-01)
2025-02-26	K250281	El.En S.P.A.	DEKA LOTUS
2024-11-14	K242440	Nanjing Bestview Laser S&T Co., Ltd.	Intense Pulsed Light Treatment System (LK-PT)
2024-08-21	K240314	Guangzhou Ciellulu Photoelectric Technology Co., Ltd.	MULA (K2-A1)
2024-05-17	K240482	Smedtrum Medical Technology Co., Ltd.	Intense Pulsed Light System (ST-690)
2024-05-16	K233473	El.En S.P.A.	DEKA LOTUS
2024-03-15	K233307	Beijing Adss Development Co., Ltd.	Intensity Pulsed Light Therapy System
2023-12-01	K232708	Hebei Zhemai Technology Co., Ltd.	Intense pulsed light therapy device
2023-09-11	K232192	Venus Concept, Inc.	Venus Versa PRO System
2023-08-09	K231394	Smedtrum Medical Technology Co., Ltd.	Intense Pulsed Light System
2023-04-21	K230816	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System
2023-02-18	K220214	Shanghai Omni Laser Skinology Co., Ltd.	Painless IPL System - KDT750
2022-11-10	K220794	Tentech Co. , Ltd.	10PL
2022-09-21	K221214	Shenzhen Ionka Medical Technology Co., Ltd.	Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
2022-08-12	K220385	Beijing Globalipl Development Co., Ltd.	Intense Pulsed Light Equipment
2022-03-08	K213558	Ulike Co., Ltd.	IPL Hair Removal Device
2021-12-02	K212907	Kam Yuen Plastic Products , Ltd.	Aimanfun Lumea Comfort, A-2789/A-3588
2021-10-04	K211368	Shenzhen Mywin Technology Co., Ltd.	IPL Hair Remover, Model: G993, G996, G998 and G885
2021-09-24	K212099	Shenzhen Accompany Technology Co., Ltd.	Red Wave Hair Removal
2021-05-21	K210119	Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.	IPL Hair Removal Device (Model: KCA423)
2020-06-11	K200616	E-Swin	E>EyeC
2020-05-15	K200746	Shanghai Apolo Medical Technology Co., Ltd.	IPL Treatment Systems