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FDA 510(k)

TANDA MINI SKINCARE SYSTEM

K-Number: K124042 · 2013-04-02

ApplicantSyneron Beauty
Decision Date2013-04-02
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANDA MINI SKINCARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Beauty. It received FDA 510(k) clearance on 2013-04-02 under 510(k) number K124042. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDA MINI SKINCARE SYSTEM?

TANDA MINI SKINCARE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-02. The listed applicant is Syneron Beauty. The 510(k) number is K124042.

When did TANDA MINI SKINCARE SYSTEM receive FDA 510(k) clearance?

TANDA MINI SKINCARE SYSTEM received FDA 510(k) clearance on 2013-04-02, under 510(k) number K124042.

Who is the listed applicant for TANDA MINI SKINCARE SYSTEM?

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 MINI SKINCARE SYSTEM?

The FDA product code for TANDA MINI SKINCARE SYSTEM is OLP.

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 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.

K122725TANDA PEARL, ULTRAWYTE, PEARL

Related Devices (Code: OLP)

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.

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.

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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