Manufacturer
Boston Aesthetics, Inc.Boston iFace (Boston iFace)
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251988
- Device name
- Boston iFace (Boston iFace)
- Company
- Boston Aesthetics, Inc.
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-06-27
- Decision date
- 2026-01-12
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- Pain ManagementOther
- Primary application
- Pain Management
- Classification source
- AI classified
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.
Intended 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.
Device Description
The Boston iFace is mainly composed of a host, a footswitch, a handpiece, a hand switch, a power cord, tip connectors, tips and a trolley. The Boston iFace is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field. The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy.
Summary parsed at:2026-06-19 23:51:27 UTC
Predicate devices
3—
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Not ingested
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Not ingested
Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
K251988 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251988 as a predicate