510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252146Substantially Equivalent

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

Shenzhen Siken 3D Technology Development Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252146 is the FDA 510(k) clearance record for Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209), a class II device, cleared for Shenzhen Siken 3D Technology Development Co., Ltd. on under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes). FDA records list 6 510(k) clearances for Shenzhen Siken 3D Technology Development Co., Ltd., from to . As of , FDA records show no recalls naming K252146.

Clearance record

Decision date
Received
(167 days to decision)
Product code
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Shenzhen Siken 3D Technology Development Co., Ltd. Rm.1104, Bldg. 2, Xinweirun High-Tech Park, # 162, Shajiang, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFO

Trailing 12 months
9 clearances under product code NFO in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NFO, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20260
May 20262
June 20261
July 20261
August 20261
September 20262
October 20260