Intense Pulsed Light Therapy Device (MMABM-1)

The Intense Pulsed Light Therapy Device (MMABM-1) is a medical device using a broadband xenon flash lamp with wavelengths of 420-1200 nm for non-ablative dermatological treatments. It is indicated for treating moderate inflammatory acne vulgaris, benign pigmented epidermal lesions, benign cutaneous vascular lesions, and permanent hair reduction using interchangeable optical filters.

The device uses an Intense Pulsed Light (xenon flash lamp) source with six optical filters (420, 515, 560, 590, 640, 695 nm) delivering pulse energies of 1.9-236.2 J and energy densities of 5-35 J/cm² depending on filter wavelength. It features variable pulse train widths (5-500 ms for 420 nm; 5-200 ms for other filters), pulse intervals of 1-5 seconds, and multiple handpiece tips (7 mm round, 11 mm round, 15 mm square, 45 mm × 15 mm rectangular).

IEC 60601-1 Edition 3.2 (electrical safety), IEC 60601-1-6 Edition 3.2 (usability), IEC 60601-1-2 Edition 4.1 (electromagnetic disturbances), IEC 62471 First Edition (photobiological safety), and IEC 60601-2-57 Edition 1.0 (non-laser light source equipment). Product life acceleration testing and software verification/validation per FDA guidance were also performed.

The subject device is substantially equivalent to the predicate (ST-690, K240482) because both use the same Intense Pulsed Light xenon flash lamp technology with overlapping wavelength ranges (420-1200 nm), share identical light delivery via handpiece, address the same clinical indications, and comply with the same regulatory standards. Although minor differences exist in filter options, fluence ranges, pulse widths, and spot sizes, these variations are within the performance envelope of the predicate and do not introduce new safety or effectiveness concerns.