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FDA 510(k)

Gladiator

K-Number: K233099 · 2024-05-22

ApplicantRohrer Aesthetics, LLC
Decision Date2024-05-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gladiator is a medical device manufactured by Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2024-05-22 under approval number K233099. 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 Gladiator?

Gladiator is a medical device that received FDA 510(k) clearance on 2024-05-22. It is manufactured by Rohrer Aesthetics, LLC. The 510(k) number is K233099.

When was Gladiator approved by the FDA?

Gladiator received FDA 510(k) clearance on 2024-05-22, under approval number K233099.

What company makes Gladiator?

Gladiator is manufactured by Rohrer Aesthetics, LLC.

What is the FDA product code for Gladiator?

The FDA product code for Gladiator is GEI.

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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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