Cleared Traditional

LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)

K243040 · Shenzhen Siken 3D Technology Development Co., Ltd. · General & Plastic Surgery

Dec 2024

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K243040 is an FDA 510(k) clearance for the LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Shenzhen Siken 3D Technology Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 20, 2024, 84 days after receiving the submission on September 27, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K243040 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	December 20, 2024
Days to Decision	84 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OHS — Light Based Over The Counter Wrinkle Reduction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.