South Korea Urges Caution with At-Home Laser Hair Loss Devices, Cites Need for Clinical validation
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Amid a surge in popularity, South Korean regulators are advising consumers to verify the efficacy and safety of at-home laser devices marketed for hair loss treatment.The Ministry of Food and Drug Safety (MFDS) issued the warning on Thursday, July 25, as more companies – including major electronics manufacturers like LG – release devices promising to combat hair loss.
The growing consumer interest stems from the accessibility of these devices, but officials caution that not all products live up to their claims. A senior official stated that the MFDS is actively working to ensure that only approved products reach the market and that consumers are fully informed.
Understanding hair Loss and Available Treatments
Hair loss, defined as the absence of hair in areas where it typically grows, is a common concern with diverse causes. According to the MFDS, genetic predisposition and hormonal imbalances often contribute to a shortened hair growth cycle, leading to premature shedding and thinning. over time, this process can diminish the size of hair follicles and reduce hair density.
To address this,a range of laser devices for hair loss treatment have emerged,categorized by the MFDS as Class 3 medical devices – indicating a moderate risk of potential harm. These devices utilize laser technology intended to stimulate hair growth.
Rigorous Testing Through human Clinical Trials
the MFDS is currently evaluating the efficacy and effectiveness of these laser devices through comprehensive human clinical trials. The process for determining eligibility for these trials adheres to strict regulations governing medical device licensing,reporting,and review.
During these trials, researchers assess improvements in hair count in the targeted areas before and after device use. This data is crucial for determining whether a device meets the necessary standards for approval.
Crucial Steps for Consumers
Before purchasing or using a laser hair loss device, the MFDS strongly recommends two critical steps:
- Accurate Diagnosis: Consult a specialist to determine the specific type of hair loss you are experiencing.
- Device Matching: Ensure the laser device is specifically approved for treating your diagnosed condition.
Consumers can verify a product’s approval status by searching the online ‘Medical Device Safe Bookstore’. Even with an approved device, strict adherence to the user manual is paramount, including recommended usage frequency and duration.
Safety Precautions and Contraindications
The MFDS also issued several meaningful safety warnings:
- Avoid Direct Eye Exposure: Never look directly at the laser light.
- Discontinue use: Promptly stop using the device and consult a specialist if you experience unbearable itching, pain, blisters, or skin redness.
- Pre-existing Conditions: Do not use the device if you have wounds or diseases on your scalp, or if you have photosensitive skin.
- Pregnancy & Lactation: Pregnant, potentially pregnant, or lactating women should not use these devices.
The Ministry of Food and Drug Safety emphasizes that responsible use, guided by professional diagnosis and adherence to safety guidelines, is essential for maximizing the potential benefits of these emerging hair loss tr
