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FDA 510(k)

TANDA RESTORE, MODEL PTSCS

K-Number: K090008 · 2009-10-15

ApplicantPharos Life Corporation
Decision Date2009-10-15
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TANDA RESTORE, 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 2009-10-15 under 510(k) number K090008. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDA RESTORE, MODEL PTSCS?

TANDA RESTORE, MODEL PTSCS is a medical device that received FDA 510(k) clearance on 2009-10-15. The listed applicant is Pharos Life Corporation. The 510(k) number is K090008.

When did TANDA RESTORE, MODEL PTSCS receive FDA 510(k) clearance?

TANDA RESTORE, MODEL PTSCS received FDA 510(k) clearance on 2009-10-15, under 510(k) number K090008.

Who is the listed applicant for TANDA RESTORE, 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 RESTORE, MODEL PTSCS?

The FDA product code for TANDA RESTORE, MODEL PTSCS is ILY.

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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.

K110735TANDA MAX OTC SYSTEMK103415TANDA MAXK080591TANDA SKINCARE SYSTEM, MODEL: PTSCSK070185TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

Related Devices (Code: ILY)

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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