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FDA 510(k)

Accent XL

K-Number: K160075 · 2016-08-17

ApplicantAlma Lasers, Inc.
Decision Date2016-08-17
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Accent XL 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 2016-08-17 under 510(k) number K160075. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accent XL?

Accent XL is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K160075.

When did Accent XL receive FDA 510(k) clearance?

Accent XL received FDA 510(k) clearance on 2016-08-17, under 510(k) number K160075.

Who is the listed applicant for Accent XL?

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 Accent XL?

The FDA product code for Accent XL is IMI.

Other records listing Alma Lasers, Inc. as applicant

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Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , 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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