FDA 510(k)

PINXEL-RF system

K-Number: K180654 · 2018-07-13

Decision Date2018-07-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PINXEL-RF system is a medical device manufactured by Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2018-07-13 under approval 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. It is manufactured by Rohrer Aesthetics, LLC. The 510(k) number is K180654.

When was PINXEL-RF system approved by the FDA?

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

What company makes PINXEL-RF system?

PINXEL-RF system is manufactured by Rohrer Aesthetics, LLC.

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

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