Home / 510(k) Clearances / K252553

510(k) 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) by Shenzhen Jianchao Intelligent Technology Co., Ltd. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2025
Date Received
August 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Shenzhen Jianchao Intelligent Technology Co., Ltd.

  • K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD0 (January 30, 2026)
  • K242710 — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16- (December 6, 2024)
  • K232575 — Hair Removal Device, Model(s): R2815-G Pro, R2815-G (November 20, 2023)

Other clearances for product code NFO

  • K252187 — Aura Glide (FC40) (December 23, 2025)
  • K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB (December 23, 2025)
  • K250618 — Medi Lift Essential Eye Mask (October 29, 2025)
  • K250227 — JOVS Electric Stimulation Beauty Device (JE2) (October 17, 2025)
  • K251034 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare (October 12, 2025)
  • K251649 — Sunny Plus (Sunny) (September 18, 2025)
  • K251909 — NeurotriS (SX2500); NeurotriS (SX3800) (September 3, 2025)
  • K252218 — MF SC GEN2 Facial Toning System (July 18, 2025)
  • K244004 — Microcurrent Facial Device (CEC101, EE0101, EEI101) (July 10, 2025)
  • K250361 — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (May 23, 2025)