FDA 510(k)

Boston iFace (Boston iFace)

K-Number: K251988 · 2026-01-12

Decision Date2026-01-12

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Boston Aesthetics, Inc.. The 510(k) number is K251988.

When was Boston iFace (Boston iFace) approved by the FDA?

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

What company makes Boston iFace (Boston iFace)?

Boston iFace (Boston iFace) is manufactured by Boston Aesthetics, Inc..

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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Official Source

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