Cleared Traditional

K163470 - Galvanic Spa, Model: SKB-1405
(FDA 510(k) Clearance)

K163470 · Shenzhen Siken 3D Technology Development Co., Ltd. · Neurology

Jun 2017

Decision

172d

Days

Class 2

Risk

K163470 is an FDA 510(k) clearance for the Galvanic Spa, Model: SKB-1405. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO).

Submitted by Shenzhen Siken 3D Technology Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 2, 2017, 172 days after receiving the submission on December 12, 2016.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K163470 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2016
Decision Date	June 02, 2017
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF