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FDA 510(k)

TANDA MAX

K-Number: K103415 · 2011-01-03

ApplicantPharos Life Corporation
Decision Date2011-01-03
Product CodeONE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANDA MAX 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 2011-01-03 under 510(k) number K103415. The device is classified under product code ONE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDA MAX?

TANDA MAX is a medical device that received FDA 510(k) clearance on 2011-01-03. The listed applicant is Pharos Life Corporation. The 510(k) number is K103415.

When did TANDA MAX receive FDA 510(k) clearance?

TANDA MAX received FDA 510(k) clearance on 2011-01-03, under 510(k) number K103415.

Who is the listed applicant for TANDA MAX?

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 MAX?

The FDA product code for TANDA MAX is ONE.

Related Clinical Trials

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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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 SYSTEMK090008TANDA RESTORE, MODEL PTSCSK080591TANDA SKINCARE SYSTEM, MODEL: PTSCSK070185TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

Related Devices (Code: ONE)

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.

K250224handLITE (TN19S)iSMART Developments, Ltd.K171055Philips BlueControlPhilips Electronics Nederland B.V.K100628PLASMALUXLSDaavlin Distributing Co.K091467BABY QUASARSilver Bay, LLCK091125CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2VeriluxK092800ANTI-WRINKLE (AGING) LIGHT, MODEL AALLed Intellectual Properties, LLC

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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