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FDA 510(k)

TANDA PEARL, ULTRAWYTE, PEARL

K-Number: K122725 · 2012-11-27

ApplicantSyneron Beauty
Decision Date2012-11-27
Product CodeEEG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TANDA PEARL, ULTRAWYTE, PEARL is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Beauty. It received FDA 510(k) clearance on 2012-11-27 under 510(k) number K122725. The device is classified under product code EEG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDA PEARL, ULTRAWYTE, PEARL?

TANDA PEARL, ULTRAWYTE, PEARL is a medical device that received FDA 510(k) clearance on 2012-11-27. The listed applicant is Syneron Beauty. The 510(k) number is K122725.

When did TANDA PEARL, ULTRAWYTE, PEARL receive FDA 510(k) clearance?

TANDA PEARL, ULTRAWYTE, PEARL received FDA 510(k) clearance on 2012-11-27, under 510(k) number K122725.

Who is the listed applicant for TANDA PEARL, ULTRAWYTE, PEARL?

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

What is the FDA product code for TANDA PEARL, ULTRAWYTE, PEARL?

The FDA product code for TANDA PEARL, ULTRAWYTE, PEARL is EEG.

Related Clinical Trials

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Other records listing Syneron Beauty 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.

K124042TANDA MINI SKINCARE SYSTEM

Related Devices (Code: EEG)

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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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