Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

The Sculpt LED Belt is a wearable device that emits LED light in red (630nm) and infrared (850nm, 940nm) or green (532nm) wavelengths. It is indicated for non-invasive dermatological aesthetic treatment for reduction of body circumference in the hips, waist, and thighs, and for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, and stiffness through topical heating. The device is powered by a rechargeable lithium battery or AC adapter and operates for 10-20 minutes per treatment session.

The Sculpt LED Belt uses LED light sources at wavelengths of 630nm, 850nm, and 940nm with irradiances ranging from 4.2 to 60 mW/cm² depending on mode. Key design differences from predicates include the combination of three wavelengths in one device (versus predicates using two wavelengths), wearable belt form factor, and availability of both battery-powered and adapter-powered models. Electrical safety compliance includes IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, and IEC 62471; biocompatibility meets ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23.

IEC 60601-1 (medical electrical equipment safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment requirements), IEC 60601-2-83 (home light therapy equipment), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), ISO 10993 series (biocompatibility), and FDA guidance on software verification and validation.