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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 the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) 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. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K181298.

When did Harmony XL Multi-Application Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for Harmony XL Multi-Application Platform?

The FDA 510(k) record lists Alma Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Alma Lasers, Inc. as applicant

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Related Devices (Code: ONF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.

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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