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FDA 510(k)

truSculpt flex

K-Number: K212866 · 2022-12-03

ApplicantJohari Digital Healthcare Limited
Decision Date2022-12-03
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

truSculpt flex is a medical device manufactured by Johari Digital Healthcare Limited. It received FDA 510(k) clearance on 2022-12-03 under approval number K212866. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the truSculpt flex?

truSculpt flex is a medical device that received FDA 510(k) clearance on 2022-12-03. It is manufactured by Johari Digital Healthcare Limited. The 510(k) number is K212866.

When was truSculpt flex approved by the FDA?

truSculpt flex received FDA 510(k) clearance on 2022-12-03, under approval number K212866.

What company makes truSculpt flex?

truSculpt flex is manufactured by Johari Digital Healthcare Limited.

What is the FDA product code for truSculpt flex?

The FDA product code for truSculpt flex is NGX.

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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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