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FDA 510(k)

truSculpt iD

K-Number: K223110 · 2022-11-03

ApplicantCutera, Inc.
Decision Date2022-11-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

truSculpt iD is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K223110. 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 truSculpt iD?

truSculpt iD is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Cutera, Inc.. The 510(k) number is K223110.

When did truSculpt iD receive FDA 510(k) clearance?

truSculpt iD received FDA 510(k) clearance on 2022-11-03, under 510(k) number K223110.

Who is the listed applicant for truSculpt iD?

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

What is the FDA product code for truSculpt iD?

The FDA product code for truSculpt iD is GEI.

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Official Source

View on FDA Database →

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

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