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FDA 510(k)

Boston iFace (Boston iFace)

K-Number: K251988 · 2026-01-12

ApplicantBoston Aesthetics, Inc.
Decision Date2026-01-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing Boston Aesthetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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