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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 the device name listed in this FDA 510(k) record. The listed applicant is Rohrer Aesthetics. It received FDA 510(k) clearance on 2023-10-25 under 510(k) 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. The listed applicant is Rohrer Aesthetics. The 510(k) number is K233147.

When did PiXel8-RF receive FDA 510(k) clearance?

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

Who is the listed applicant for PiXel8-RF?

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

What is the FDA product code for PiXel8-RF?

The FDA product code for PiXel8-RF 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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