Boston Aesthetics, Inc. · Class II · Cleared Jan 12, 2026
| K-number | K251988 |
| Device name | Boston iFace (Boston iFace) |
| Applicant | Boston Aesthetics, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Jan 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The Boston iFace is a radiofrequency device with a touchscreen-controlled host unit, handpieces, footswitch, and accessories. It is intended for heating tissue to rise temperature for medical conditions including temporary relief of pain, muscle spasms, and promotion of local circulation.
The Boston iFace is a state-of-the-art radiofrequency device with a large color touchscreen for user guidance, on-screen therapy parameters, hand-operated buttons on handpieces for easier control, and a trolley for mobility. Bench testing evaluated output power, operating frequency, temperature protection functions, thermal effects, and skin surface temperature.
IEC 60601-1 (general medical electrical equipment safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-2 (high frequency surgery equipment), ISO 10993-5:2009 (cytotoxicity), ISO 10993-23:2021 (skin irritation), and ISO 10993-10:2021 (skin sensitization).
The subject device and predicate device (K211639, BTL-785W) have the same intended use and regulatory classification. Differences in technological characteristics do not raise new safety or effectiveness concerns. Bench testing demonstrated the device performs as intended and is as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov