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Dr. Pen Microneedling System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230420

by Guangzhou Ekai Electronic Technology Co., Ltd.

Identifiers

510(k) Number
K230420 FDA 510(k)
FDA Product Code
QAI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4430 FDA 510(k)
Regulation Number
878.4430 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dr. Pen Microneedling System is a Powered Microneedle Device, designed to deliver controlled microneedling treatments to the skin. It employs a handheld pen with interchangeable microneedle cartridges to create microchannels, facilitating improved absorption of topical skincare products and promoting collagen remodeling for skin rejuvenation. Suitable for dermatological and cosmetic applications, it operates under precise depth and speed controls to ensure safety and efficacy during procedures.

This device is intended for single-use or reusable microneedle cartridges, depending on the model, and is classified as a Class II medical device under FDA regulations. Supplied sterile or non-sterile based on cartridge type, it requires proper handling, storage, and adherence to manufacturer guidelines to maintain performance and sterility. The system is authorized for use in general and plastic surgery settings, with multiple registration numbers listed under FDA clearance (K230420). Compliance with 510(k) clearance ensures its regulatory standing for controlled microneedling applications.

Frequently asked questions

What is the Dr. Pen Microneedling System used for?

The Dr. Pen Microneedling System is designed to create controlled microchannels in the skin, enhancing the absorption of topical skincare products and stimulating collagen remodeling. This promotes skin rejuvenation and is primarily used in dermatological and cosmetic procedures, including general and plastic surgery settings.

Are the microneedle cartridges single-use or reusable?

The Dr. Pen Microneedling System offers both single-use and reusable microneedle cartridges, depending on the specific model. Single-use cartridges ensure sterility for each procedure, while reusable cartridges may be used multiple times with proper cleaning, sterilization, and adherence to manufacturer guidelines to maintain safety and performance.

How is sterility maintained with this device?

Sterility depends on the cartridge type—some are supplied sterile, while others are non-sterile. For reusable cartridges, strict cleaning, sterilization, and storage protocols must be followed to prevent contamination. Always refer to the manufacturer’s instructions to ensure proper handling and sterility.

What depth and speed controls does the device offer?

The Dr. Pen Microneedling System includes precise depth and speed controls to ensure safe and effective microneedling treatments. These adjustments allow clinicians to customize the procedure based on patient needs, minimizing risk while optimizing results for skin rejuvenation.

What regulatory approval does this device hold?

The Dr. Pen Microneedling System holds FDA 510(k) clearance (K230420) as a Class II medical device, classified under regulation number 878.4430. This clearance confirms its compliance with U.S. safety and performance standards for powered microneedle devices in controlled clinical applications.

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: Ekai: Microneedling Pen Brand for Global Distributors, Guangzhou Ekai Electronic Technology Co., Ltd., Guangzhou Ekai Electronic Technology Co., Ltd., Guangzhou Ekai Electronic Technology Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Ekai Electronic Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K230420 24 fields · synced Oct 1, 2026