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FDA 510(k)

Harmony XL Multi-Application Platform

K-Number: K181298 · 2018-06-13

ApplicantAlma Lasers, Inc.
Decision Date2018-06-13
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Harmony XL Multi-Application Platform is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K181298. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harmony XL Multi-Application Platform?

Harmony XL Multi-Application Platform is a medical device that received FDA 510(k) clearance on 2018-06-13. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K181298.

When was Harmony XL Multi-Application Platform approved by the FDA?

Harmony XL Multi-Application Platform received FDA 510(k) clearance on 2018-06-13, under approval number K181298.

What company makes Harmony XL Multi-Application Platform?

Harmony XL Multi-Application Platform is manufactured by Alma Lasers, Inc..

What is the FDA product code for Harmony XL Multi-Application Platform?

The FDA product code for Harmony XL Multi-Application Platform is ONF.

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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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