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Face Patches (MT-12MA, MT-12MC)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240089

by Shenzhen Kaiyan Medical Equipment Co, . Ltd

Identifiers

510(k) Number
K240089 FDA 510(k)
FDA Product Code
OHS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Face Patches (MT-12MA, MT-12MC) are classified as Light-Based Over-the-Counter Wrinkle Reduction Devices under FDA product code OHS. These single-use adhesive patches incorporate light-emitting elements designed to target superficial skin wrinkles and fine lines through controlled phototherapy, aiming to improve skin texture and appearance without invasive procedures.

Intended for at-home use, these patches are non-reusable and supplied sterile in individual packaging. They are classified as Class II devices under 21 CFR 878.4810, with an FDA 510(k) clearance (K240089) granted under the Substantially Equivalent (SESE) determination. Storage instructions specify protection from moisture and direct sunlight, and they are regulated under the General, Plastic Surgery advisory committee. No MRI safety information is provided.

Frequently asked questions

Are these Face Patches reusable or designed for single-use only, and how should they be stored?

The Face Patches (MT-12MA, MT-12MC) are explicitly designed for single-use only and come sterile in individual packaging. To maintain their integrity, they must be stored protected from moisture and direct sunlight as per the manufacturer’s instructions.

What types of skin concerns are these patches intended to address, and how do they work?

These patches are light-based over-the-counter wrinkle reduction devices intended for superficial skin wrinkles and fine lines. They use controlled phototherapy to target skin texture and appearance improvements, making them suitable for at-home use without invasive procedures.

Are there any special handling instructions for these patches, such as compatibility with other treatments or MRI safety?

The manufacturer does not provide MRI safety information, so these patches should not be used near MRI machines. No additional compatibility details with other treatments are specified, so users should follow the at-home instructions provided and avoid combining them with untested procedures.

How do I know if these patches are legally approved for use in my country?

These patches hold an FDA 510(k) clearance (K240089) under the Substantially Equivalent (SESE) determination, meaning they meet U.S. regulatory standards for Class II medical devices. However, approvals in other countries depend on local regulatory bodies, so verify compliance with your region’s health authorities.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Face Patches (MT-12MA, MT-12MC) (K240089) — FDA 510 (k) | Innolitics, K240089 FDA 510 (k) - Face Patches (MT-12MA, Face Patches (MT-12MA, MT-12MC) 510 (k) K240089 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Kaiyan Medical Equipment Co, . Ltd
FDA Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.

Sources (1)

  • FDA 510(k) K240089 24 fields · synced Oct 6, 2026