EnergyLounger (TY-01)

The EnergyLounger (TY-01) is an LED-based therapeutic device designed as a recliner with 1,260 LED lights for three treatment modes: M1 reduces circumference of hips, waist, and thighs; M2 treats full-face wrinkles using visible and infrared energy; M3 provides topical heating for temporary relief of minor muscle and joint pain, arthritis, and muscle spasm. The device operates over-the-counter with automatic shutoff after 20-30 minutes depending on mode.

The device uses a 4-in-1 LED configuration with wavelengths of 630nm, 850nm, and 940nm, delivering irradiance of 4.2-60 mW/cm² depending on mode. It has 1,260 total LEDs with uniform distribution across the full body treatment area and powered by 100-240VAC 50/60Hz input with 12VDC output. Key differences from predicates include slightly different wavelength combinations and LED count, but irradiance levels align with predicate devices.

IEC 60601-1 Edition 3.2 (electrical safety), IEC 60601-1-11 (home healthcare use), IEC 60601-2-57 (therapeutic light source safety), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), IEC 62471 (photobiological safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), IEC 62366-1 and IEC 60601-1-6 (usability).

The device demonstrates substantial equivalence because it uses the same fundamental technology (LED-based light therapy) with comparable indications for use and intended locations (full-body treatment for wrinkles, circumference reduction, and pain relief) as three legally marketed predicates. Though wavelengths and LED counts differ slightly, the submission argues these variations do not raise safety or effectiveness concerns since irradiance levels are equivalent and all designs comply with the same IEC safety standards. Non-clinical testing confirms electrical safety, biocompatibility, and usability compliance, making it functionally equivalent to predicate devices already on the market.