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FDA 510(k)

TRIA LASER HAIR REMOVAL SYSTEM

K-Number: K120737 · 2012-09-13

ApplicantTria Beauty, Inc.
Decision Date2012-09-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIA LASER HAIR REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tria Beauty, Inc.. It received FDA 510(k) clearance on 2012-09-13 under 510(k) number K120737. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIA LASER HAIR REMOVAL SYSTEM?

TRIA LASER HAIR REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is Tria Beauty, Inc.. The 510(k) number is K120737.

When did TRIA LASER HAIR REMOVAL SYSTEM receive FDA 510(k) clearance?

TRIA LASER HAIR REMOVAL SYSTEM received FDA 510(k) clearance on 2012-09-13, under 510(k) number K120737.

Who is the listed applicant for TRIA LASER HAIR REMOVAL SYSTEM?

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

What is the FDA product code for TRIA LASER HAIR REMOVAL SYSTEM?

The FDA product code for TRIA LASER HAIR REMOVAL SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Tria Beauty, Inc. 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.

K160821Tria SapphireK130459TRIA FAN SYSTEMK090312TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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