FDA 510(k)

Boston iFace (Boston iFace)

N.º K: K251988 · 2026-01-12

Fecha de decisión2026-01-12

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Boston iFace (Boston iFace) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K251988. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Boston iFace (Boston iFace)?

Boston iFace (Boston iFace) is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K251988.

When did Boston iFace (Boston iFace) receive FDA 510(k) clearance?

Boston iFace (Boston iFace) received FDA 510(k) clearance on 2026-01-12, under 510(k) number K251988.

Who is the listed applicant for Boston iFace (Boston iFace)?

The FDA 510(k) record lists Boston Aesthetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boston iFace (Boston iFace)?

The FDA product code for Boston iFace (Boston iFace) is GEI.

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Fuente oficial

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