IPL Treatment Device (MDSQMC-01)

The IPL Treatment Device (Model MDSQMC-01) is an intense pulsed light system that delivers light at wavelengths from 400–1200 nm for surgical and aesthetic applications. It is intended for permanent hair removal, reduction of benign pigmented lesions, benign vascular lesions, and treatment of mild to moderate inflammatory acne. Permanent hair reduction is defined as long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months after treatment completion.

The device operates on selective thermolysis principles, delivering multiple wavelengths per pulse (unlike single-wavelength lasers) to target specific chromophores. Key specifications include energy density of 10–35 J/cm², pulse width of 3–20 ms, spot sizes of 10×45 mm to 80×40 mm, and maximum power of 2400 VA. The handpiece uses sapphire crystal for patient contact. Wavelength options include 400–600 nm for acne and multiple filter selections up to 1200 nm for hair and vascular lesions.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (skin irritation); IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-57 (non-laser light source equipment); IEC 62471 (photobiological safety); FDA guidance on human factors and usability engineering (February 2016).

The subject device has identical intended use, mode of action (selective thermolysis), and operational principles as the predicate device (Shandong Huamei HM-IPL-B8, K230816). Although minor differences exist in wavelength options, energy density ranges, and spot sizes, these variations fall within clinically acceptable parameters and do not raise safety or efficacy concerns. Performance data demonstrates biocompatibility, electrical safety, and EMC compliance equivalent to the predicate. The device was compared against two additional reference devices with similar specifications, all using the same IPL technology for the same indications.