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FDA 510(k)

BodySculp

K-Number: K212331 · 2021-11-09

ApplicantRohrer Aesthetics, LLC
Decision Date2021-11-09
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BodySculp is the device name listed in this FDA 510(k) record. The listed applicant is Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K212331. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BodySculp?

BodySculp is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Rohrer Aesthetics, LLC. The 510(k) number is K212331.

When did BodySculp receive FDA 510(k) clearance?

BodySculp received FDA 510(k) clearance on 2021-11-09, under 510(k) number K212331.

Who is the listed applicant for BodySculp?

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

What is the FDA product code for BodySculp?

The FDA product code for BodySculp is PKT.

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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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