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Rejuvapen NXT Powered Microneedle Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192138

by Refine USA, LLC

Identifiers

510(k) Number
K192138 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 Rejuvapen NXT is a powered microneedle device designed for controlled skin penetration to stimulate collagen production and improve skin texture. Classified as a Powered Microneedle Device, it employs an array of stainless steel needle cartridges to deliver microneedling treatments for aesthetic purposes, including skin rejuvenation and periorbital wrinkle reduction.

This device is intended for single-use applications in clinical settings, such as dermatology or plastic surgery offices. Supplied sterile and non-reusable, it operates under FDA 510(k) clearance (K192138) and falls under regulation number 878.4430 as a Class II medical device. Needle cartridges are available in multiple reference codes, ensuring compatibility with various treatment requirements.

Frequently asked questions

What types of skin treatments is the Rejuvapen NXT specifically designed to address?

The Rejuvapen NXT is designed for aesthetic skin rejuvenation and targeted treatment of periorbital wrinkles. It uses controlled microneedling to stimulate collagen production, improving skin texture and reducing fine lines around the eyes.

Is the Rejuvapen NXT intended for reuse in clinical settings, or is it single-use?

The Rejuvapen NXT is explicitly designed for single-use applications in clinical settings like dermatology or plastic surgery offices. This ensures patient safety and sterility, as it is supplied sterile and not meant for reuse.

How many needle cartridge options are available for the Rejuvapen NXT, and what determines compatibility?

The Rejuvapen NXT offers multiple needle cartridge reference codes, each tailored to different treatment requirements. Compatibility is ensured by matching the cartridge’s reference code to the specific model or depth setting needed for the procedure.

What regulatory pathway does the Rejuvapen NXT follow, and how was its equivalence determined?

The Rejuvapen NXT follows the FDA 510(k) clearance pathway (K192138) and is classified as a Class II medical device under regulation number 878.4430. Its equivalence was determined through a traditional 510(k) review, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness) by the Skin (SU) Advisory Committee for General and Plastic Surgery.

How should the Rejuvapen NXT be stored, and is there any special handling required?

Since the Rejuvapen NXT is sterile and single-use, it should be stored in a clean, dry environment as per manufacturer guidelines (Refine USA, LLC). Avoid exposure to extreme temperatures or moisture, and ensure the packaging remains intact until use to maintain sterility.

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: Rejuvapen NXT® - Refine USA, Medical Aesthetic Devices | Refine USA, Aesthetic Technologies | Rejuvapen NXT by Refine USA | Jacksonville Beach

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Refine USA, LLC

Sources (1)

  • FDA 510(k) K192138 24 fields · synced Sep 18, 2026