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FDA 510(k)

TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC

K-Number: K090312 · 2010-01-05

ApplicantTria Beauty, Inc.
Decision Date2010-01-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC 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 2010-01-05 under 510(k) number K090312. 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 ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC?

TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC is a medical device that received FDA 510(k) clearance on 2010-01-05. The listed applicant is Tria Beauty, Inc.. The 510(k) number is K090312.

When did TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC receive FDA 510(k) clearance?

TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC received FDA 510(k) clearance on 2010-01-05, under 510(k) number K090312.

Who is the listed applicant for TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC?

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 ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC?

The FDA product code for TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC 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 SYSTEMK120737TRIA LASER HAIR REMOVAL SYSTEM

Related Devices (Code: GEX)

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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