APR's Booster Pro officially reported to US FDA as unapproved medical device

APR's flagship beauty device, the Medicube Booster Pro, has been officially reported to the US Food and Drug Administration (FDA) adverse event reporting system on suspicion of being marketed as an unapproved Class II medical device. The controversy over local regulatory violations of its main product comes as the North American market has become APR's largest revenue source.

According to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database on Nov. 8, an official report (report number MW5175339) was filed regarding the Medicube Booster Pro sold by APR's US subsidiary. The report alleged that the company is illegally marketing the product as a medical device without proper FDA registration, misleading consumers and posing health risks.

The reporter stated that Medicube advertises medical benefits for the Booster Pro, including absorption enhancement, radiance improvement, elasticity management, facial contouring, pore care, and microcurrent. Such claims, which imply intent to treat or alter physiological functions of the body, should classify the device as a Class II medical device under FDA guidelines. The reporter argued that APR's sale of the device without registration violates Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In the US market, devices that use microcurrent or radiofrequency to change facial contours or stimulate muscles are generally classified as Class II medical devices and require FDA 510(k) premarket clearance. NuFACE, a local microcurrent beauty device, is a representative example. APR has distributed the Booster Pro as a general beauty device rather than a medical device, but marketing language emphasizing structural body improvement has sparked regulatory controversy.

The FDA's MAUDE is a database where consumers, healthcare professionals, and manufacturers can voluntarily report adverse events or product problems related to medical devices. The fact that a report has been filed does not itself mean an FDA violation determination or immediate sanctions. However, if specific reports regarding unapproved medical device claims accumulate in the official system, it could lead to substantive actions such as an FDA investigation or import alert.

The United States is the largest market driving APR's performance. According to disclosures, APR recorded cumulative provisional revenue of 2.134 trillion won (about $1.6 billion) in the first three quarters of this year, already surpassing last year's annual figure, with overseas sales accounting for 94% of total revenue. In particular, North America and Europe accounted for 69% of overseas revenue in the third quarter. If regulatory barriers arise for the Booster Pro, which leads sales on major local channels such as Amazon and TikTok Shop, it could affect overall performance.

Previously, in August last year, a consumer report regarding the Medicube Booster Pro was also filed in the FDA adverse event reporting system. That report also included allegations of skin irritation side effects and that the product was being sold as a medical device without authorization.

(Dollar figures are approximate, converted automatically at 1,000 won = $0.735, the rate on Nov. 10, 2026.)

※ This article is an AI translation of the Korean original published by Korea Credit News; it was checked by automated quality guards and published by the English edition desk.