Aura Glide (FC40)

The Aura Glide is a handheld, over-the-counter aesthetic device for home use with two interchangeable attachments. The microcurrent attachment is indicated for facial stimulation at three intensity levels, and the LED attachment delivers red light (633 nm) for periorbital wrinkles and blue light (415 nm) for mild to moderate inflammatory acne. The device is powered by a rechargeable lithium battery and includes a conductive gel primer for microcurrent treatments.

Both subject and predicate devices are handheld, Type BF isolated, home-use units with software-controlled preset treatment modes and automatic shut-off. The Aura Glide uses slightly different wavelengths (633 nm red, 415 nm blue vs. 630 nm, 415 nm), has a smaller irradiation area (22.5 cm² vs. 26 cm²), lower battery capacity (600 mAh vs. 2200 mAh), and slightly different electrical output parameters. The subject device adds a plastic shield over LEDs and uses chrome-plated electrodes instead of stainless steel.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-2-57, IEC 62133-2, IEC 62366-1, IEC 62471, ISO 10993-5, ISO 10993-10, and ISO 10993-23. Testing confirmed compliance with medical electrical equipment safety, electromagnetic compatibility, battery safety, biocompatibility (cytotoxicity, skin sensitization, irritation), and usability standards.

The Aura Glide is substantially equivalent to the Heat In Click 2 Face/Face Evolution predicate device because both are handheld, over-the-counter aesthetic devices with identical indications for use (facial stimulation and light-based treatment of wrinkles and acne), same regulatory classification (Class II), product codes, and treatment area. Minor differences in weight, dimensions, materials, wavelengths, irradiation area, and electrical parameters do not raise safety or effectiveness concerns, as demonstrated by comprehensive testing showing compliance with applicable safety standards.