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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 a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2022-11-03 under approval 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. It is manufactured by Cutera, Inc.. The 510(k) number is K223110.

When was truSculpt iD approved by the FDA?

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

What company makes truSculpt iD?

truSculpt iD is manufactured by Cutera, Inc..

What is the FDA product code for truSculpt iD?

The FDA product code for truSculpt iD is GEI.

Other Devices by Cutera, Inc.

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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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