Unregulated Laser Procedures by Korean Medicine Doctors... Gaps in Patient Protection Persist

No Precedent or Administrative Standard for Determining Provider Eligibility

Compensation Unlikely if Procedures Deemed Beyond License Scope

As debates between the Korean Medical Association (hereafter KMA) and the Association of Korean Medicine (hereafter AKOM) over the use of laser and high-frequency aesthetic devices by Korean medicine doctors continue, concerns are mounting over the lack of adequate protections for the patients who actually undergo these procedures. There are no definitive precedents in the courts specifying eligibility to use such devices, nor are there administrative guidelines to substitute. As a result, it remains unclear whether patients can receive compensation if adverse effects like burns or scars occur.

According to sources in the medical field as of August 10, there are no explicit regulations addressing the use of advanced medical devices by Korean medicine doctors, leading only to an accumulation of case-by-case administrative rulings. Recently, as companies specializing in aesthetic medical devices, starting with Classys, have announced the suspension of supply to clinics and dental offices, the conflict has reignited. However, the government has yet to provide guidelines on the issue.

The absence of clear standards has directly resulted in a gap in patient protection. Both medical professional liability insurance and the Korean Medicine Mutual Aid Association's plan are designed on the assumption of ‘legitimate medical practices within the scope of a practitioner’s license.’ If the procedure is deemed to fall outside the license, insurers may have grounds for exemption. This uncertainty makes it difficult even for the insurance industry to guarantee compensation for incidents.

According to an industry insider, "Medical professional liability insurance products are not standardized like indemnity or auto insurance, so coverage and compensation criteria can differ between companies." The source added, "If a procedure does not fall clearly within the scope of a Korean medicine doctor’s license, it is highly likely that insurance payout will be difficult." Due to the fact that insurance terms cannot themselves directly determine the licensed scope defined under the Medical Service Act, the responsible government ministry or the courts must first interpret the matter before compensation can be decided. Therefore, until clear standards are established, affected patients may be forced to wait indefinitely for decisions on compensation.

Obtaining accurate data on the current situation is also difficult. Since most aesthetic procedures are not covered by the national health insurance, it is challenging to estimate the scale of such practices based only on health insurance claim data. There is also a lack of official statistics specifically compiling the possession and use of aesthetic medical devices by Korean medicine clinics. Consequently, some experts are pointing out that safety management for patients is being overshadowed by the ongoing conflict between medical and Korean medicine circles over the use of these devices.

40-Year-Long Regulatory Vacuum over Korean Medicine Doctors’ Use of Aesthetic Devices

Previously, the aesthetic medical device company Classys announced it would discontinue managing the supply of devices to Korean medicine clinics and dental offices. AKOM strongly protested, but without clear statutory guidelines, confusion is spreading further. Other companies producing laser and high-frequency devices, such as Solta Medical Korea and Won Tech, have taken similar actions, worsening the dispute.

The companies have stated that this is a "distribution policy, not a judgment about legality," but without consumables and maintenance, it becomes virtually impossible to operate the equipment. As a result, the ambiguous qualifications for use among different medical professions are now being effectively determined by the companies’ risk-aversion policies. AKOM claims it is under pressure from medical organizations and is considering reporting the matter to the Fair Trade Commission, while KMA has stated that it "has not interfered with distribution."

Judicial interpretations remain limited to diagnostic devices. The December 2022 Supreme Court en banc ruling only addressed the use of ultrasound diagnostic devices. Subsequent lower court decisions concerning electroencephalogram and X-ray bone densitometers have also been confined to diagnostic equipment. As of now, there are no Supreme Court or lower court precedents specifically addressing devices—such as lasers or high-frequency units—that act directly on tissue during procedures.

The responsible ministry's position has remained unchanged for over 40 years. Since the Ministry of Health and Social Affairs issued an interpretation regarding laser acupuncture in 1987, there have been occasional further clarifications. However, the most recent instance the Ministry of Health and Welfare could confirm dates back 14 years, to June 2012. Even then, the ministry only stated that devices like Fraxel (fractional laser) might be considered "acts similar to acupuncture (such as stimulation of acupoints)," not as a comprehensive guideline for all types of aesthetic medical devices.

The Ministry of Health and Welfare maintains that it is difficult to issue a one-size-fits-all interpretation. Unless a device operates on principles that clearly correspond to traditional Korean medicine—such as close similarity to acupuncture—it is difficult to make a blanket judgment about the use of modern aesthetic medical devices. The ministry says it must consider the operating mechanism, invasiveness, and the practitioner's education and level of proficiency. A ministry official commented, "We are responding to public inquiries in line with the intent of Supreme Court rulings and future case law as it develops."

This content was produced with the assistance of AI translation services.