Peninsula Medical becomes the first domestic company to obtain the Class III medical device certificate for RF microneedling.

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The first “Class III medical device certificate” for domestically produced RF microneedling devices (commonly known as “golden microneedles”) has arrived.

On October 29, Peninsula Medical announced that its RF skin treatment device (hereinafter referred to as “Peninsula Anti-aging Timer”) has officially been approved for the Class III Medical Device Registration Certificate.

This is the first domestic golden microneedling device to obtain the “Class III certificate.”

Prior to this, the Peninsula Anti-aging Timer had already obtained the FDA 510(k) registration certificate. With this newly approved domestic Class III certificate, it has become the first domestically produced RF microneedling device certified by both the NMPA and FDA.

The approval of the “Class III certificate” aligns with the regulatory direction of relevant authorities for golden microneedle and other RF products.

In July 2024, the National Medical Products Administration issued an “Announcement on Further Clarifying Relevant Requirements for RF Therapeutic Device Products”, requiring that from April 1, 2026, RF therapeutic devices and RF skin treatment device products must upgrade from Class II medical device certificates to Class III medical device registration certificates.

This has prompted Peninsula Medical and other companies to accelerate alignment with the standards of the “Class III certificate” to seize market initiative after regulatory upgrades.

According to Peninsula Medical, the “Peninsula Anti-aging Timer” integrates three RF microneedling modes—monopolar, bipolar, and combined mono-bipolar. When combined with “dynamic layering technology,” it can treat different parts of the skin while ensuring concentrated energy output, eliminating the need for multiple sessions for different needs as with traditional projects, thus saving time and greatly reducing discomfort during the treatment process. It is mainly used to treat acne and similar conditions.

With the approval of Peninsula Anti-aging Timer this time, domestic RF product offerings are expected to expand.

Xinfeng has noted that in March of this year, Huadong Medicine’s (000963.SZ) optical RF treatment device V30’s application for the “Class III certificate” has been accepted by the National Medical Products Administration.

Unlike the “Peninsula Anti-aging Timer,” which uses microneedling, Huadong Hospital’s V30 mainly utilizes laser energy, combining RF, intense pulsed light, and Nd:YAG laser energy sources, and is intended for skin firming, hair removal, vascular and pigment lesion treatment, acne, and more.

Overall, regulatory upgrades have not restricted industry development. Instead, by setting “compliance thresholds,” they are screening for companies with stronger technical capabilities, driving the development of domestic RF products from quantitative expansion to quality competition, and further accelerating the process of domestic substitution.

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