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FDA 510(k)

PINXEL-RF system

K-Number: K180654 · 2018-07-13

ApplicantRohrer Aesthetics, LLC
Decision Date2018-07-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PINXEL-RF system 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 2018-07-13 under 510(k) number K180654. 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 PINXEL-RF system?

PINXEL-RF system is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Rohrer Aesthetics, LLC. The 510(k) number is K180654.

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

PINXEL-RF system received FDA 510(k) clearance on 2018-07-13, under 510(k) number K180654.

Who is the listed applicant for PINXEL-RF system?

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 PINXEL-RF system?

The FDA product code for PINXEL-RF system 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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