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

Clearance details

Applicant

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Product code

Product code OHS

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2025-12-01

Decision date

2026-01-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K260767 — Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more2026-08-31
• K261602 — Eye Recovery Pro (PH-e03)2026-08-10
• K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)2026-08-07
• K261496 — LED Light Therapy Masks (PE748, PE749, PE756)2026-08-04
• K261851 — LED Light Therapy Mask (5 models)2026-08-04

• K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)2026-10-09
• K262834 — Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)2026-10-09
• K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)2026-08-10
• 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)2025-10-09
• 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)2024-12-06

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 →