510(k) K253833— 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)

Substantially Equivalent

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Clearance details

Applicant: Shenzhen Jianchao Intelligent Technology Co., Ltd.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2025-12-01
Decision date: 2026-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.