After Beauty Devices Comes Medical Devices, and the Regulatory Bar Is Different

What is the signal?

APR's current articles of incorporation include the development, manufacture and sale of medical device consumables, the development, manufacture and sale of medical instruments, and medical device repair among its business purposes. Recent reporting describes two lines in preparation. One is a skin booster using polynucleotides (PN); the other is an energy-based device (EBD) for clinics that delivers energy such as radiofrequency (RF) or ultrasound into the skin. Reports also said the company is going through domestic approval procedures with the aim of a launch in Korea as early as this year.

The background cited is a change in revenue mix. As the cosmetics business grew faster, the share of beauty devices in total revenue fell from 43% in 2024 to 18% in the first half of 2026. With competition in home beauty devices intensifying, the move reads as an attempt to diversify the profit portfolio.

This is not one company's decision alone. The Samjong KPMG Economic Research Institute set out six structural shifts in its report on the evolving beauty device market in the era of skin longevity: the expansion of home care built on small devices; skinification, where the managed area widens from the face to the scalp and body; BaaS (Beauty-as-a-Service) combining devices with cosmetics and consumables; AI-driven hyper-personalization; medical device and pharmaceutical companies entering B2C; and the global expansion of K-beauty devices. The same report put the global beauty device market at $7.787 billion in 2017, growing to $14.724 billion in 2023.

Two things should be kept separate when reading this signal. First, the presence of a related business purpose in the articles of incorporation provides a basis for conducting that business; it does not mean an individual product has been approved. Reporting that approval is in progress and the actual launch date are different matters. Second, market size figures vary widely by institution because the scope and definition differ. Samjong KPMG forecast the Korean market at $488.4 million in 2030, while another research firm put the Korean beauty device market at roughly $1.5 billion as of 2025. Rather than deciding which is correct, note that they count different things as a device, and read direction rather than absolute scale.

1. The same skin device can sit in a different regulatory lane

Home-use beauty appliances and clinic-grade medical devices may look similar to a consumer, but they fall into different boxes in the regulatory system. In Korea, medical devices are split between approval, certification and notification depending on class, and Class 3 and 4 devices, along with Class 1 and 2 devices that are not substantially equivalent to an already approved, certified or notified device, require approval. Compared with cosmetics, the reviewing body, the documents to submit, and what may be said in advertising are all different.

In practice, the first place this difference shows up is in wording. A sentence that cannot be used for a cosmetic may be possible for a medical device within the approved intended use, and conversely a product without medical device approval that uses that wording runs into trouble. If devices and cosmetics will be sold under one brand, the copy for the two product groups should be managed separately from the start.

So it is better to invert the order of judgment. Fix which regulatory category the product falls into before asking how to introduce it, and write the copy after that. Reverse the order and you end up remaking packaging and product pages that have already been produced.

2. As devices grow, the role of cosmetics changes too

BaaS (Beauty-as-a-Service), one of the shifts Samjong KPMG named, refers to a structure that does not end at selling a device but bundles cosmetics and consumables with it. A consumer who buys one device then repeatedly purchases a dedicated gel, cartridge or ampoule. For the brand, revenue occurs more than once.

In this structure, the cosmetic is less a companion product than a component designed on the assumption that the device operates. Conductivity, viscosity, slip, residue and compatibility with the device surface become criteria, where they mattered less in standalone use. Getting scent and sensory feel right is not enough for the product to work with the device.

So if a device and a cosmetic are planned together, it causes less rework to start the formulation discussion at the same time as the device specification rather than after it. Once the device structure is fixed, the room a formula has to adapt narrows.

• Is this product premised on use with a device, or does it stand alone?
• Who verifies compatibility between the device contact surface and the formula, and at which stage?
• Has the consumable repurchase cycle been designed into the product volume?
• Are the advertising claims for the device and the cosmetic managed separately?

3. Skinification is a formulation redesign, not a line extension

The widening of managed areas from the face to the scalp and body shows up in devices and in cosmetics alike. But when the area changes, the same concept does not carry over as a formula. Scalp products have to account for hair and the cleansing process, and body products involve an application area and per-use amount that are not comparable to the face.

A larger use amount also means a different cost structure. Carrying the ratio of an expensive ingredient from a facial product straight into a body product often makes the price unworkable. Cut the ingredient back, and the difference the consumer notices disappears.

So it is better to treat area expansion as a separate plan rather than a larger size of the same product. Agreeing early with the manufacturing partner on which ingredients to hold at what level and which elements to rebuild for the area makes it easier to set the price range for the whole line.

4. The clinic channel judges by different criteria

For clinic devices and treatment products, the buying decision is made by the practitioner, not the consumer. Whether it holds up under repeated use, how long a treatment takes, and what a consumable costs move to the front. Packaging design and brand narrative, which work in consumer channels, move comparatively to the back.

A different channel also means a different kind of evidence. In consumer channels, satisfaction after use or perceived change is used to persuade; in clinic channels, the approved intended use and the data supporting it are the starting point of the conversation. The types of documents to prepare are different.

When a home care brand struggles to move into this channel, the difficulty usually comes from this gap rather than from technology. It is worth checking which channel's language your current materials are written in.

5. Smaller brands can start with the seat next to the device

The medical device business requires both capital and time, so it is not a path every brand can follow immediately. But as the device market grows, demand grows alongside it for the cosmetics the devices need. Products used before and after device use, dedicated formats used together with a device, and low-irritation formulas intended for post-treatment use are all such seats.

If you aim for that seat, the differentiator is not the ingredient list but the condition. It has to be clear which device and which use situation the product was made for. That is different work from adding 'use with your device' to a generic product.

At the same time, wording that suggests a procedure or a therapeutic effect easily goes beyond the scope of a cosmetic. You can aim for the seat next to the device while keeping the claims inside cosmetic standards, and that boundary is safest to settle at the brief stage.

The first question for the brief

Write this on the first line of the brief: is this product a cosmetic or a medical device, and how does that answer change our advertising copy and the documents we have to submit? What a brand should take from the news that the beauty device market is widening toward medical devices is not 'let us build a device too', but the habit of fixing which regulatory box a product falls into first. Once the box is set, the decisions that follow come much faster.