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FDA 510(k)

The Alma Opus System, Colibri Applicator and Tips

K-Number: K201520 · 2021-10-27

ApplicantAlma Lasers, Inc.
Decision Date2021-10-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The Alma Opus System, Colibri Applicator and Tips is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2021-10-27 under approval number K201520. 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 The Alma Opus System, Colibri Applicator and Tips?

The Alma Opus System, Colibri Applicator and Tips is a medical device that received FDA 510(k) clearance on 2021-10-27. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K201520.

When was The Alma Opus System, Colibri Applicator and Tips approved by the FDA?

The Alma Opus System, Colibri Applicator and Tips received FDA 510(k) clearance on 2021-10-27, under approval number K201520.

What company makes The Alma Opus System, Colibri Applicator and Tips?

The Alma Opus System, Colibri Applicator and Tips is manufactured by Alma Lasers, Inc..

What is the FDA product code for The Alma Opus System, Colibri Applicator and Tips?

The FDA product code for The Alma Opus System, Colibri Applicator and Tips 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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