Cleared Traditional

Medi Lift Essential Eye Mask

K250618 · Ya-Man, Ltd. · Neurology
Oct 2025
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K250618 is an FDA 510(k) clearance for the Medi Lift Essential Eye Mask, a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Ya-Man, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on October 29, 2025, 243 days after receiving the submission on February 28, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K250618 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2025
Decision Date October 29, 2025
Days to Decision 243 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

Similar Devices — NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 74
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
K252146 · Shenzhen Siken 3D Technology Development Co., Ltd. · Dec 2025
Aura Glide (FC40)
K252187 · Aura Medical, LLC · Dec 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · Shenzhen Qianyu Technology Co., Ltd. · Oct 2025
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
K251034 · Shenzhen Nuon Medical Equipment Co., Ltd. · Oct 2025
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 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Oct 2025
Sunny Plus (Sunny)
K251649 · ShenB Co., Ltd. · Sep 2025