Cleared Traditional

K251034 - Radiant Renewal Skincare Lid (HD-59A

Also marketed or referenced as:
Radiant Renewal Skincare Wand (HD-44)

K251034 is an FDA 510(k) clearance for Radiant Renewal Skincare Lid (HD-59A, manufactured by Shenzhen Nuon Medical Equipment Co., Ltd.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K251034 · Shenzhen Nuon Medical Equipment Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
192d
Days
Class 2
Risk

K251034 is an FDA 510(k) clearance for the Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70). Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Shenzhen Nuon Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 12, 2025 after a review of 192 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Nuon Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K251034

510(k) Number K251034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2025
Decision Date October 12, 2025
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 148d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 53
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K251034.
Aura Glide (FC40)
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Medi Lift Essential Eye Mask
K250618 · Ya-Man, Ltd. · Oct 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · Shenzhen Qianyu Technology 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
NeurotriS (SX2500)
K251909 · A-1 Engineering · Sep 2025