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FDA 510(k)

TANDA SKINCARE SYSTEM, MODEL: PTSCS

K-Number: K080591 · 2008-11-14

ApplicantPharos Life Corporation
Decision Date2008-11-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANDA SKINCARE SYSTEM, MODEL: PTSCS is the device name listed in this FDA 510(k) record. The listed applicant is Pharos Life Corporation. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K080591. 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 TANDA SKINCARE SYSTEM, MODEL: PTSCS?

TANDA SKINCARE SYSTEM, MODEL: PTSCS is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Pharos Life Corporation. The 510(k) number is K080591.

When did TANDA SKINCARE SYSTEM, MODEL: PTSCS receive FDA 510(k) clearance?

TANDA SKINCARE SYSTEM, MODEL: PTSCS received FDA 510(k) clearance on 2008-11-14, under 510(k) number K080591.

Who is the listed applicant for TANDA SKINCARE SYSTEM, MODEL: PTSCS?

The FDA 510(k) record lists Pharos Life Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TANDA SKINCARE SYSTEM, MODEL: PTSCS?

The FDA product code for TANDA SKINCARE SYSTEM, MODEL: PTSCS is GEX. This falls under the Gastroenterology category.

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Other records listing Pharos Life Corporation 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.

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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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