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FDA 510(k)

ACCENT

K-Number: K070004 · 2007-04-23

ApplicantAlma Lasers , Ltd.
Decision Date2007-04-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCENT is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers , Ltd.. It received FDA 510(k) clearance on 2007-04-23 under 510(k) number K070004. 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 ACCENT?

ACCENT is a medical device that received FDA 510(k) clearance on 2007-04-23. The listed applicant is Alma Lasers , Ltd.. The 510(k) number is K070004.

When did ACCENT receive FDA 510(k) clearance?

ACCENT received FDA 510(k) clearance on 2007-04-23, under 510(k) number K070004.

Who is the listed applicant for ACCENT?

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

What is the FDA product code for ACCENT?

The FDA product code for ACCENT is GEI.

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Other records listing Alma Lasers , Ltd. as applicant

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.

K212073Alma Diode Tabletop LaserK203441The Alma Hybrid Laser SystemK170850Alma QK090571ALMA LASERS ALEX755 MODULEK083848ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORMK082622ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE

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Related Devices (Code: GEI)

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.

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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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