OHS · Light Based Over The Counter Wrinkle Reduction
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | OHS |
|---|---|
| Device Name | Light Based Over The Counter Wrinkle Reduction |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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 161)
Showing 20 most recent of 161 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Aug 7, 2026 | SESE |
| K261851 | 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) | Shenzhen Qianyu Technology Co., Ltd. | Aug 4, 2026 | SESE |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | Aug 4, 2026 | SESE |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | Jul 31, 2026 | SESE |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | Jul 24, 2026 | SESE |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. | Jul 15, 2026 | SESE |
| K261473 | Chromix | Termosalud S.L. | Jul 1, 2026 | SESE |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | Jun 29, 2026 | SESE |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | Jun 18, 2026 | SESE |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jun 16, 2026 | SESE |
| K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | Jun 3, 2026 | SESE |
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | May 12, 2026 | SESE |
| K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | Apr 22, 2026 | SESE |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | Mar 23, 2026 | SESE |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | Mar 16, 2026 | SESE |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | Mar 16, 2026 | SESE |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | Mar 3, 2026 | SESE |
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo, Inc. | Feb 20, 2026 | SESE |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. | Feb 12, 2026 | SESE |
| K253833 | 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) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | Jan 30, 2026 | SESE |
Top Applicants
- Shenzhen Kaiyan Medical Equipment Co., Ltd. — 15 clearances
- Led Technologies, Inc. — 9 clearances
- Light Tree Ventures Europe B.V. — 7 clearances
- Led Intellectual Properties, LLC — 6 clearances
- Guangdong Newdermo Biotech Co., Ltd. — 4 clearances
