Cleared Traditional

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

K252553 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Neurology
Oct 2025
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K252553 is an FDA 510(k) clearance for the Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Shenzhen Jianchao Intelligent Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 9, 2025, 57 days after receiving the submission on August 13, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K252553 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2025
Decision Date October 09, 2025
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

Similar Devices — NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 74
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
K252146 · Shenzhen Siken 3D Technology Development Co., Ltd. · Dec 2025
Aura Glide (FC40)
K252187 · Aura Medical, LLC · Dec 2025
Medi Lift Essential Eye Mask
K250618 · Ya-Man, Ltd. · Oct 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · Shenzhen Qianyu Technology Co., Ltd. · Oct 2025
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
K251034 · Shenzhen Nuon Medical Equipment Co., Ltd. · Oct 2025
Sunny Plus (Sunny)
K251649 · ShenB Co., Ltd. · Sep 2025