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FDA 510(k)

TRIA HAIR REMOVAL LASER SYSTEM

K-Number: K090820 · 2009-12-23

ApplicantSpectragenics, Inc.
Decision Date2009-12-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIA HAIR REMOVAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spectragenics, Inc.. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K090820. 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 HAIR REMOVAL LASER SYSTEM?

TRIA HAIR REMOVAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Spectragenics, Inc.. The 510(k) number is K090820.

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

TRIA HAIR REMOVAL LASER SYSTEM received FDA 510(k) clearance on 2009-12-23, under 510(k) number K090820.

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

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

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

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

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Other records listing Spectragenics, 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.

K053527SPECTRA HAIR REMOVAL LASERK060567SPECTRAGENICS ATS-1K052848SPECTRA HAIR REMOVAL LASERK032846SPECTRA PULSED DIODE LASER, MODEL DR-1

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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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