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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 a medical device manufactured by Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2021-11-09 under approval 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. It is manufactured by Rohrer Aesthetics, LLC. The 510(k) number is K212331.

When was BodySculp approved by the FDA?

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

What company makes BodySculp?

BodySculp is manufactured by Rohrer Aesthetics, LLC.

What is the FDA product code for BodySculp?

The FDA product code for BodySculp is PKT.

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Related Devices (Code: PKT)

K160470SculpSureCynosure, Inc. K171992SculpSureCynosure, Inc. K171111SculpsureCynosure, Inc. K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. K180511Eon FRDominion Aesthetic Technologies, Inc. K182741SculpSureCynosure

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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