Cleared Traditional

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

K253833 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · General & Plastic Surgery

Jan 2026

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K253833 is an FDA 510(k) clearance for the Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Shenzhen Jianchao Intelligent Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 30, 2026, 60 days after receiving the submission on December 1, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K253833 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2025
Decision Date	January 30, 2026
Days to Decision	60 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.