# K251988: Boston iFace (Boston iFace)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Aesthetics, Inc.
- Decided: Jan 12, 2026 after 199 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 288 ancestors in all.
No later device cites it as a predicate yet.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211639: BTL-785W, BTL Industries, Inc. (2022) Summary page 5.

## Indications for use
The Boston iFace is intended to be used for heating to rise tissue temperature, which is used for selected medical conditions, such as temporary relief of pain, muscle spasms, and promotion of local circulation.

Source page: https://510kreport.com/device/K251988
Methodology: https://510kreport.com/methodology