Cleared Traditional

K252264 - MEGELIN LED Light Therapy Mask (JML1

Also marketed or referenced as:
MEGELIN LED Light Therapy Mask (JML3, JML3+JML4) MEGELIN LED Light Therapy Mask (JML5, JML5+JML7) MEGELIN LED Light Therapy Mask (JML6, JML6+JML8) MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

K252264 is an FDA 510(k) clearance for MEGELIN LED Light Therapy Mask (JML1, manufactured by Shenzhen Zhenxing Ruitong Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K252264 · Shenzhen Zhenxing Ruitong Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
88d
Days
Class 2
Risk

K252264 is an FDA 510(k) clearance for the MEGELIN LED Light Therapy Mask (JML1, JML1+JML2). Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Shenzhen Zhenxing Ruitong Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 17, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Zhenxing Ruitong Technology Co., Ltd. devices

FDA 510(k) Submission Details - K252264

510(k) Number K252264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2025
Decision Date October 17, 2025
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OHS Light Based Over The Counter Wrinkle Reduction

All 120
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K252264.
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