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FDA 510(k)

Galvanic Spa, Model: SKB-1405

K-Number: K163470 · 2017-06-02

ApplicantShenzhen Siken 3D Technology Development Co., Ltd.
Decision Date2017-06-02
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Galvanic Spa, Model: SKB-1405 is a medical device manufactured by Shenzhen Siken 3D Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2017-06-02 under approval number K163470. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Galvanic Spa, Model: SKB-1405?

Galvanic Spa, Model: SKB-1405 is a medical device that received FDA 510(k) clearance on 2017-06-02. It is manufactured by Shenzhen Siken 3D Technology Development Co., Ltd.. The 510(k) number is K163470.

When was Galvanic Spa, Model: SKB-1405 approved by the FDA?

Galvanic Spa, Model: SKB-1405 received FDA 510(k) clearance on 2017-06-02, under approval number K163470.

What company makes Galvanic Spa, Model: SKB-1405?

Galvanic Spa, Model: SKB-1405 is manufactured by Shenzhen Siken 3D Technology Development Co., Ltd..

What is the FDA product code for Galvanic Spa, Model: SKB-1405?

The FDA product code for Galvanic Spa, Model: SKB-1405 is NFO.

Other Devices by Shenzhen Siken 3D Technology Development Co., Ltd.

K222710IPL Cooling Hair Removal Device K232845IPL Cooling Hair Removal Device K243040LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

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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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