Cleared Traditional

K261407 - XPREEN LED Light Therapy Masks (XPRE322

K261407 is the FDA 510(k) clearance for XPREEN LED Light Therapy Masks (XPRE322 by Dongguan Miqiang Technology Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code OHS) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K261407 · Dongguan Miqiang Technology Co., Ltd. · General & Plastic Surgery device
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Jul 2026
Decision
77d
Days
Class 2
Risk

K261407 is an FDA 510(k) clearance for the XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, .... Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Dongguan Miqiang Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on July 15, 2026 after a review of 77 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 Dongguan Miqiang Technology Co., Ltd. devices

Submission Details

510(k) Number K261407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2026
Decision Date July 15, 2026
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K261407.
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LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
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Ulike Reglow Light Therapy Device (UM10)
K260511 · Shenzhen Ulike Smart Electronics Co., Ltd. · Mar 2026