NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes Class II
FDA product code NFO covers "Stimulator, Transcutaneous Electrical, Aesthetic Purposes", a Class II medical device regulated under 21 CFR 882.5890. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NFO
- Device Class
- Class II
- Regulation Number
- 882.5890
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260179 | touchbeauty beauty and health (shenzhen) co | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | June 3, 2026 |
| K260895 | guangxi ulike medical technology co | Ulike Clear Zero (YC10 BU) | May 28, 2026 |
| K252621 | el global trade | DeepSkin (DEP100) | May 8, 2026 |
| K252146 | shenzhen siken 3d technology development co | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB | December 23, 2025 |
| K252187 | aura medical | Aura Glide (FC40) | December 23, 2025 |
| K250618 | ya-man | Medi Lift Essential Eye Mask | October 29, 2025 |
| K250227 | shenzhen qianyu technology co | JOVS Electric Stimulation Beauty Device (JE2) | October 17, 2025 |
| K251034 | shenzhen nuon medical equipment co | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare | October 12, 2025 |
| K252553 | shenzhen jianchao intelligent technology co | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C | October 9, 2025 |
| K251649 | shenb co | Sunny Plus (Sunny) | September 18, 2025 |
| K251909 | a-1 engineering | NeurotriS (SX2500); NeurotriS (SX3800) | September 3, 2025 |
| K252218 | micro current technology | MF SC GEN2 Facial Toning System | July 18, 2025 |
| K244004 | shenzhen dachi communication co | Microcurrent Facial Device (CEC101, EE0101, EEI101) | July 10, 2025 |
| K250361 | geske beauty tech | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | May 23, 2025 |
| K243072 | ema aesthetics | Préime DermaFacial (MicroT) | April 1, 2025 |
| K243587 | xtreem pulse | PureLift GLOW | March 6, 2025 |
| K243063 | raja trading company | Myolight Microcurrent Handpiece | February 10, 2025 |
| K243393 | shenzhen ulike smart electronics co | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30 | February 3, 2025 |
| K244048 | ya-man | Medi Lift Mask | January 16, 2025 |
| K243430 | shenzhen aozemei technology co | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | December 19, 2024 |