OHS · Light Based Over The Counter Wrinkle Reduction

Device class

Class II

Regulation 878.4810

Total clearances

118

2020-06-22 → 2026-08-10

Last 12 months

Unique sponsors

Definition

What is Light Based Over The Counter Wrinkle Reduction

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

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 Equipment Co., Ltd.	15	4	2026-06-16
Light Tree Ventures Europe B.V.	7	1	2026-05-12
Guangdong Newdermo Biotech Co., Ltd.	4	3	2026-06-29
Shenzhen Qianyu Technology Co., Ltd.	3	1	2026-08-04
Foreo, Inc.	3	1	2026-02-20
Led Technologies, Inc.	3	0	2022-12-21
Shenzhen Ulike Smart Electronics Co., Ltd.	3	2	2026-03-16
Shenzhen Kaiyan Medical CO , Ltd.	3	0	2022-05-17
iSMART Developments, Ltd.	3	1	2026-07-24
Yrs Group, Inc.	2	0	2022-07-22
Shenzhen Goodwind Technology Development Co., Ltd.	2	2	2026-08-10
Shenzhen Nuon Medical Equipment Co., Ltd.	2	0	2025-04-08
Sunglor Technology Co., Ltd.	2	2	2025-12-19
Lyma Life , Ltd.	2	0	2025-02-21
Y & J Bio Co., Ltd.	2	0	2022-11-17
Led Intellectual Properties, LLC	2	1	2026-07-31
Shenzhen Siken 3D Technology Development Co., Ltd.	2	1	2025-12-05
Merchsource, LLC	2	2	2025-10-16
Duplex International Trading Limited	2	1	2026-08-04
Heat IN A Click, LLC	2	1	2025-12-24
Premier North America, Inc.	2	0	2024-03-01
Shenzhen Rainbow Technology Co., Ltd.	2	1	2026-01-23
Shenzhen Liyoutong Technology Co., Ltd.	1	0	2025-08-07
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.	1	1	2025-12-19
Shenzhen Idea Light Limited	1	0	2024-01-12

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	—	Low	Unlisted procedure, dermatology; OTC device may not have billable clinical code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-10	K261602	Shenzhen Goodwind Technology Development Co., Ltd.	Eye Recovery Pro (PH-e03)
2026-08-07	K261601	Shenzhen Chuangtong Yigou Technology Co., Ltd.	LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
2026-08-04	K261851	Shenzhen Qianyu Technology Co., Ltd.	LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)
2026-08-04	K261496	Duplex International Trading Limited	LED Light Therapy Masks (PE748, PE749, PE756)
2026-07-31	K261482	Led Intellectual Properties, LLC	LightStim for Wrinkles (1984); LightStim for Acne (2038)
2026-07-24	K260598	iSMART Developments, Ltd.	5 Wavelength LED Facemask (TN2508)
2026-07-15	K261407	Dongguan Miqiang Technology Co., Ltd.	XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
2026-07-01	K261473	Termosalud S.L.	Chromix
2026-06-29	K261052	Guangdong Newdermo Biotech Co., Ltd.	LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
2026-06-18	K260946	Guangdong Newdermo Biotech Co., Ltd.	LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
2026-06-16	K254025	Shenzhen Kaiyan Medical Equipment Co., Ltd.	LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
2026-06-03	K260715	The Beauty Tech Group, Ltd.	CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
2026-05-12	K260415	Light Tree Ventures Europe B.V.	myLEDmask 2 (MJ-144)
2026-04-22	K260150	NOOANCE	LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
2026-03-23	K260202	Guangdong Newdermo Biotech Co., Ltd.	LED Light Therapy Masks (LumiLips FAC07NA)
2026-03-16	K260511	Shenzhen Ulike Smart Electronics Co., Ltd.	Ulike Reglow Light Therapy Device (UM10)
2026-03-16	K254079	Shenzhen Desida Technology Co., Ltd.	LED Light Therapy Mask (Models: T2, RLD10)
2026-03-03	K253874	Shenzhen Hanhua Opto Co., Ltd.	LED Therapy Light (COB1400, HP1800PRO)
2026-02-20	K253683	Foreo, Inc.	FAQ (LED Panel); FAQ (Dual LED Panel)
2026-02-12	K254007	SZ KKS Silicone&Electronic Co., Ltd.	LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
2026-01-30	K253833	Shenzhen Jianchao Intelligent Technology Co., Ltd.	Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
2026-01-28	K252603	Shenzhen Kaiyan Medical Equipment Co., Ltd.	HIGHERDOSE Body Sculptor (Model: GS-03)
2026-01-23	K253712	Shenzhen Rainbow Technology Co., Ltd.	LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)
2025-12-24	K253400	Shenzhen Saidi Light Therapy Technology Co., Ltd.	LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
2025-12-24	K253279	Heat IN A Click, LLC	Feather/numiere 05 06 07 (05)