Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → OHS — Light Based Over The Counter Wrinkle Reduction

# OHS · Light Based Over The Counter Wrinkle Reduction

_General, Plastic Surgery · 21 CFR 878.4810 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/OHS

## Overview

- **Product Code:** OHS
- **Device Name:** Light Based Over The Counter Wrinkle Reduction
- **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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 163)

Showing 20 most recent of 163 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260767](/device/K260767.md) | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. | Aug 31, 2026 | SESE |
| [K261602](/device/K261602.md) | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | Aug 10, 2026 | SESE |
| [K261601](/device/K261601.md) | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Aug 7, 2026 | SESE |
| [K261851](/device/K261851.md) | 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](/device/K261496.md) | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | Aug 4, 2026 | SESE |
| [K261482](/device/K261482.md) | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | Jul 31, 2026 | SESE |
| [K260598](/device/K260598.md) | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | Jul 24, 2026 | SESE |
| [K261407](/device/K261407.md) | 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](/device/K261473.md) | Chromix | Termosalud S.L. | Jul 1, 2026 | SESE |
| [K261052](/device/K261052.md) | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | Jun 29, 2026 | SESE |
| [K260946](/device/K260946.md) | 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](/device/K254025.md) | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jun 16, 2026 | SESE |
| [K260715](/device/K260715.md) | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | Jun 3, 2026 | SESE |
| [K260415](/device/K260415.md) | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | May 12, 2026 | SESE |
| [K260150](/device/K260150.md) | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | Apr 22, 2026 | SESE |
| [K260202](/device/K260202.md) | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | Mar 23, 2026 | SESE |
| [K260511](/device/K260511.md) | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | Mar 16, 2026 | SESE |
| [K254079](/device/K254079.md) | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | Mar 16, 2026 | SESE |
| [K253874](/device/K253874.md) | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | Mar 3, 2026 | SESE |
| [K253683](/device/K253683.md) | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo, Inc. | Feb 20, 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

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**Source:** [https://fda-staging.innolitics.com/productcode/OHS](https://fda-staging.innolitics.com/productcode/OHS)

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