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FDA 510(k)

PiXel8-RF

K-Number: K233147 · 2023-10-25

ApplicantRohrer Aesthetics
Decision Date2023-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PiXel8-RF is a medical device manufactured by Rohrer Aesthetics. It received FDA 510(k) clearance on 2023-10-25 under approval number K233147. 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 PiXel8-RF?

PiXel8-RF is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Rohrer Aesthetics. The 510(k) number is K233147.

When was PiXel8-RF approved by the FDA?

PiXel8-RF received FDA 510(k) clearance on 2023-10-25, under approval number K233147.

What company makes PiXel8-RF?

PiXel8-RF is manufactured by Rohrer Aesthetics.

What is the FDA product code for PiXel8-RF?

The FDA product code for PiXel8-RF is GEI.

Other Devices by Rohrer Aesthetics

K233143PiXel8-Reveal

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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