Chinese Unlicensed Laser Devices for Toenail Fungus Treatment, 6.6 Billion KRW Gained through False Advertising
The Seoul City Civilian Law Enforcement Agency conducted a focused crackdown on laser toenail fungus treatment devices sold online and discovered five companies illegally manufacturing and selling products without approval from the Ministry of Food and Drug Safety.
On the 24th, Seoul City announced the results of this crackdown, revealing that the companies identified included one manufacturer and four sellers.
In particular, Company A was found to have falsely advertised an unlicensed laser device manufactured in China as effective for treating toenail fungus, selling approximately 29,000 units at 230,000 KRW each over two years. The unjust profits gained by Company A were found to amount to a staggering 6.6 billion KRW.
The Risks of Laser Treatment Devices without Medical Device Approval
Laser treatment for toenail fungus was officially registered as a "new medical technology" by the Ministry of Health and Welfare in 2015, and treatment for fungal nail infections (onychomycosis) is recognized as a non-reimbursable item, currently being performed in many dermatology clinics along with existing medication treatments.
However, the companies caught this time were found to have illegally manufactured and sold laser toenail fungus treatment devices without obtaining official approval, citing financial burdens associated with the approval process of the Food and Drug Safety Ministry.
An even more serious issue is that these companies sold their products through false advertising, knowing that their treatment had insufficient efficacy for toenail fungus. This can be viewed as a serious deception regarding medical devices, which directly relates to consumer health.
Seoul City urged citizens to prevent damage caused by unlicensed toenail fungus treatment devices by ensuring that any products purchased are clearly labeled "medical device" in Korean and confirming the "item name-item approval number" and other medical device markings.
Kim Hyun-Joong, Acting Director of the Seoul City Civilian Law Enforcement Agency, emphasized, "Unlicensed illegal medical devices pose a significant threat to public health, so we will strengthen monitoring of manufacturing and selling companies and respond sternly to any illegal activities discovered."
Seoul City plans to continue reinforcing crackdowns on illegal medical device sales that are directly related to public health.
Image source: Toenail fungus treatment devices currently sold in the market / Provided by Seoul City
