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)
FDA 510(k) K252553 · Shenzhen Jianchao Intelligent Technology Co., Ltd.
510(k) numberK252553
Submission
- Device name
- 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)
- Applicant
- Shenzhen Jianchao Intelligent Technology Co., Ltd.
Shenzhen, CN - Received
- August 13, 2025
- Decision date
- October 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262861 | PureLift Pro MaxNFO · Special | Xtreem Pulse, LLC | 09/11/2026SE |
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)NFO · Traditional | Hironic Co., Ltd. | 08/31/2026SE |
| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 07/23/2026SE |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F)NFO · Traditional | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 06/03/2026SE |
| K260895 | Ulike Clear Zero (YC10 BU)NFO · Traditional | Guangxi Ulike Medical Technology Co., Ltd. | 05/28/2026SE |
| K252621 | DeepSkin (DEP100)NFO · Traditional | El Global Trade, Ltd. | 05/08/2026SE |
| K252187 | Aura Glide (FC40)NFO · Traditional | Aura Medical, LLC | 12/23/2025SE |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…NFO · Traditional | Shenzhen Siken 3D Technology Development Co., Ltd. | 12/23/2025SE |
| K250618 | Medi Lift Essential Eye MaskNFO · Traditional | Ya-Man, Ltd. | 10/29/2025SE |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2)NFO · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 10/17/2025SE |
More from Shenzhen Qianyu Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro)OHT · Special | 08/10/2026SE |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…OHS · Traditional | 01/30/2026SE |
| K242710 | Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…OHT · Traditional | 12/06/2024SE |
| K232575 | Hair Removal Device, Model(s): R2815-G Pro, R2815-GOHT · Traditional | 11/20/2023SE |
Questions and answers
When was 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) cleared by the FDA?
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) received a 510(k) decision of Substantially Equivalent on October 9, 2025, 57 days after the submission was received.
What is the product code of K252553?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.