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)— 510(k) K253833
Substantially EquivalentShenzhen Jianchao Intelligent Technology Co., Ltd.
FDA 510(k) clearance K253833 for 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 on 2026-01-30. Applicant: Shenzhen Jianchao Intelligent Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Jianchao Intelligent Technology Co., Ltd.
- Product code
- Code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHS
view allMore clearances from Shenzhen Jianchao Intelligent Technology Co., Ltd.
view all- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
- K252553 — 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)
- K242710 — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
- K232575 — Hair Removal Device, Model(s): R2815-G Pro, R2815-G
Adverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.