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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 the device name listed in this FDA 510(k) record. The listed applicant is Johari Digital Healthcare Limited. It received FDA 510(k) clearance on 2022-12-03 under 510(k) 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. The listed applicant is Johari Digital Healthcare Limited. The 510(k) number is K212866.

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

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

Who is the listed applicant for truSculpt flex?

The FDA 510(k) record lists Johari Digital Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for truSculpt flex?

The FDA product code for truSculpt flex is NGX.

Other records listing Johari Digital Healthcare Limited 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: NGX)

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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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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