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FDA 510(k)

Acne Light Therapy Wand

K-Number: K160691 · 2016-06-21

ApplicantZuko, Inc.
Decision Date2016-06-21
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Acne Light Therapy Wand is the device name listed in this FDA 510(k) record. The listed applicant is Zuko, Inc.. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K160691. 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 Acne Light Therapy Wand?

Acne Light Therapy Wand is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Zuko, Inc.. The 510(k) number is K160691.

When did Acne Light Therapy Wand receive FDA 510(k) clearance?

Acne Light Therapy Wand received FDA 510(k) clearance on 2016-06-21, under 510(k) number K160691.

Who is the listed applicant for Acne Light Therapy Wand?

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

What is the FDA product code for Acne Light Therapy Wand?

The FDA product code for Acne Light Therapy Wand is OLP.

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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