OptiLUV Device

The OptiLUV device is a handheld RF (radiofrequency) device that emits energy at 1 MHz to heat facial tissue non-invasively. It is intended for temporary relief of minor pain and temporary increase in local blood circulation by elevating facial tissue temperature to a maximum of 41.5±1°C.

The device delivers 1.8 watts of bipolar RF energy through 4 electrodes (2 pairs) at 1±0.05 MHz frequency. It includes a thermal sensor between the electrodes that continuously monitors skin temperature and automatically disables RF transmission once the maximum safe temperature is reached. The device is non-sterile, reusable, and requires 100-240 V, 50-60 Hz electrical input.

ISO 14971:2019 (risk management), IEC 60601-1:2005 (medical electrical equipment safety), IEC 60601-1-2:2014 (electromagnetic disturbances), IEC 60601-2-2:2017 (high frequency surgical equipment), IEC 60601-1-11:2015 (home healthcare), IEC 60601-1-6:2010 (usability), IEC 62366-1:2015 (usability engineering), ISO 10993-1:2018 (biocompatibility), IEC 62304:2006 (software lifecycle), ANSI/AAMI ST98:2022 (cleaning validation), and ASTM shipping/conditioning standards.

The OptiLUV is substantially equivalent to the RF-Relief predicate (K181095) because both devices use identical RF bipolar technology at the same 1 MHz frequency, employ the same 4-electrode configuration and thermal safety mechanism, comply with identical consensus standards, and target the same adult population for facial treatment via topical heating. Although OptiLUV operates at lower power (1.8 watts vs. up to 10 watts) and as prescription-only versus OTC, these differences do not raise new safety or effectiveness concerns, as demonstrated by bench testing showing proper power accuracy and thermal control, and by clinical study showing no adverse events and maintained safe treatment temperatures over 10 minutes.