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 |
|---|---|---|---|
| K261370 | Guangdong Newdermo Biotech Co | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Sep 16, 2026 |
| K262861 | Xtreem Pulse | PureLift Pro Max | Sep 11, 2026 |
| K260387 | Hironic Co | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Aug 31, 2026 |
| K253932 | Shenzhen Kaiyan Medical Equipment Co | FACEGYM Pro Device (HD-109) | Jul 23, 2026 |
| K260179 | Touchbeauty Beauty And Health (Shenzhen) Co | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Jun 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 |
| K252187 | Aura Medical | Aura Glide (FC40) | Dec 23, 2025 |
| K252146 | Shenzhen Siken 3D Technology Development Co | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB | Dec 23, 2025 |
| K250618 | Ya-Man | Medi Lift Essential Eye Mask | Oct 29, 2025 |
| K250227 | Shenzhen Qianyu Technology Co | JOVS Electric Stimulation Beauty Device (JE2) | Oct 17, 2025 |
| K251034 | Shenzhen Nuon Medical Equipment Co | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare | Oct 12, 2025 |
| K252553 | Shenzhen Jianchao Intelligent Technology Co | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C | Oct 9, 2025 |
| K251649 | Shenb Co | Sunny Plus (Sunny) | Sep 18, 2025 |
| K251909 | A-1 Engineering | NeurotriS (SX2500); NeurotriS (SX3800) | Sep 3, 2025 |
| K252218 | Micro Current Technology | MF SC GEN2 Facial Toning System | Jul 18, 2025 |
| K244004 | Shenzhen Dachi Communication Co | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Jul 10, 2025 |
| K250361 | Geske Beauty Tech | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | May 23, 2025 |
| K243072 | Ema Aesthetics | Préime DermaFacial (MicroT) | Apr 1, 2025 |
| K243587 | Xtreem Pulse | PureLift GLOW | Mar 6, 2025 |