A South Korean skin care shop operator faced criminal charges for using a Grade 2 ultrasound beauty device without a medical license, but police cleared the case with a 'no charges' decision. The outcome signals a critical legal nuance for overseas buyers and distributors: device classification alone does not determine medical practice. The ruling hinged on four factors—risk, purpose, operator qualification, and physician involvement—offering a compliance blueprint for aesthetic clinics and device suppliers navigating regulatory gray zones.
Case background
The shop owner, identified as B, used a Grade 2 ultrasound skin care device. A beautician (A) performed the treatment after B set the mode based on the client's skin condition. The complainant argued that operating a Grade 2 medical device by a non-medical professional violated the Medical Act. Attorney Lee Il-hyung, a pharmacist-turned-medical-lawyer, defended the shop and secured a police decision not to forward the case to prosecution.
Legal principle: Device grade is not the sole criterion
"The complainant focused only on the fact that a non-medical person handled a Grade 2 device," Lee said. "But the Supreme Court does not recognize device use alone as medical practice. It requires a comprehensive assessment of purpose, risk, and method." The ruling aligns with established case law that a device's regulatory classification does not automatically make its use a medical act.
Four criteria for 'no charges'
Attorney Lee identified four factors that led to the favorable outcome: 1. **Low risk**: The device was already widely sold for home use, non-invasive, and had no reported adverse events. "We submitted evidence that the same type of device is sold in supermarkets and online to general consumers," Lee noted. "If anyone can use it at home, a professional using it in a safer environment hardly poses a public health risk." 2. **Cosmetic purpose**: The treatment was strictly for skin beauty, not disease prevention, diagnosis, or treatment. "If there had been any claim of diagnosing or treating disease, or medically guaranteed efficacy in advertising, the result could have been different," Lee said. 3. **Operator qualification**: The beautician held a valid skin care license. 4. **Physician involvement**: The owner (a medical professional) set the treatment plan, and the beautician executed it under a clear division of duties.
What buyers should watch
For overseas importers, distributors, and clinic buyers, this case underscores that compliance is not just about device registration. Key takeaways: - Verify that the device's intended use in your market is clearly cosmetic, not therapeutic. - Ensure operator training and licensing align with local regulations. - Document a clear workflow where a licensed professional oversees treatment planning. - Avoid any marketing language that implies medical diagnosis or treatment.
Sourcing context
The device in question was a Grade 2 ultrasound skin care device under Korea's Medical Device Act. Attorney Lee, leveraging his pharmacy background, reviewed the device's mechanism and safety data to argue its low risk. The case highlights that even in a strict regulatory environment like South Korea, aesthetic devices can be legally used in non-medical settings when properly positioned and operated. Distributors should consider similar legal reviews when entering new markets.
Source: Read the original report | Published: June 04, 2026