OLP · Over-The-Counter Powered Light Based Laser For Acne

Device class

Class II

Regulation 878.4810

Total clearances

2020-05-01 → 2026-03-04

Last 12 months

Unique sponsors

Definition

What is Over-The-Counter Powered Light Based Laser For Acne

The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

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
Shenzhen Kaiyan Medical CO , Ltd.	2	0	2021-07-22
Erchonia Corporation	1	1	2025-09-12
Marci Beauty, Inc.	1	0	2022-05-20
Dongguan Hunter Electronic Technology Co., Ltd.	1	0	2023-10-27
Shenzhen Eyco Technology Co., Ltd.	1	0	2025-02-05
Led Technologies, Inc.	1	0	2021-12-21
Harpar Grace International	1	0	2022-03-22
Beijing Adss Development Co., Ltd.	1	0	2020-05-01
Mz Skin	1	0	2021-11-23
Light Tree Ventures Europe B.V.	1	0	2023-07-03
Luminance Medical Ventures, Inc.	1	0	2022-06-09
Li-Tek Electronics Technology C0., Ltd.	1	0	2022-05-25
Shenzhen Osto Technology Company Limited	1	0	2022-07-07
Premier North America, Inc.	1	0	2023-11-14
Shenzhen Kaiyan Medical Equipment Co., Ltd.	1	1	2026-03-04
Ningbo Dechang Electrical Machinery Made Co.,Ltd	1	0	2025-04-04
Heat IN A Click, LLC	1	0	2021-04-16
Globalmed Technologies	1	0	2021-06-24

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
96567	CPT	—	Medium	Photodynamic therapy code; light-based acne treatment may align with phototherapy reimbursement
90834	CPT	—	Low	Light-emitting diode therapy code context-dependent; OTC device typically not reimbursed

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-04	K253878	Shenzhen Kaiyan Medical Equipment Co., Ltd.	LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
2025-09-12	K251843	Erchonia Corporation	Erchonia EVRL
2025-04-04	K242068	Ningbo Dechang Electrical Machinery Made Co.,Ltd	LED Light Therapy Mask (RT01)
2025-02-05	K243555	Shenzhen Eyco Technology Co., Ltd.	LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
2023-11-14	K232656	Premier North America, Inc.	BLU TOTALE (Model: ENEOB852)
2023-10-27	K230490	Dongguan Hunter Electronic Technology Co., Ltd.	PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
2023-07-03	K230720	Light Tree Ventures Europe B.V.	LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
2022-07-07	K213056	Shenzhen Osto Technology Company Limited	LED Facial Mask
2022-06-09	K220729	Luminance Medical Ventures, Inc.	The Luminance RED Acne Device
2022-05-25	K213039	Li-Tek Electronics Technology C0., Ltd.	Micro-current facial cold and hot service (model: TPML-100)
2022-05-20	K210545	Marci Beauty, Inc.	Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
2022-03-22	K214103	Harpar Grace International	Shani Darden LED light therapy mask
2021-12-21	K210968	Led Technologies, Inc.	reVive Light Therapy Essentials
2021-11-23	K213184	Mz Skin	MZ Skin LightMAX Supercharged LED Mask 2.0
2021-07-22	K203214	Shenzhen Kaiyan Medical CO , Ltd.	DemarkQ WOW, DemarkQ POP
2021-07-21	K203271	Shenzhen Kaiyan Medical CO , Ltd.	Aduro light therapy Handheld
2021-06-24	K210948	Globalmed Technologies	Omnilux CLEAR
2021-04-16	K202055	Heat IN A Click, LLC	Looper (Model: ZX-579S)
2020-05-01	K192295	Beijing Adss Development Co., Ltd.	PDT-FACE