Cleared Traditional

K261851 - LED Light Therapy Mask (JML1, JML1+JML2)

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

K261851 is an FDA 510(k) clearance for LED Light Therapy Mask (JML1, manufactured by Shenzhen Qianyu 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 62-day FDA review.

K261851 · Shenzhen Qianyu Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
62d
Days
Class 2
Risk

K261851 is an FDA 510(k) clearance for the 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 Qianyu Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 4, 2026 after a review of 62 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 Qianyu Technology Co., Ltd. devices

FDA 510(k) Submission Details - K261851

510(k) Number K261851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2026
Decision Date August 04, 2026
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 155
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K261851.
Eye Recovery Pro (PH-e03)
K261602 · Shenzhen Goodwind Technology Development Co., Ltd. · Aug 2026
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
K261601 · Shenzhen Chuangtong Yigou Technology Co., Ltd. · Aug 2026
LED Light Therapy Masks (PE748, PE749, PE756)
K261496 · Duplex International Trading Limited · Aug 2026
LightStim for Wrinkles (1984)
K261482 · Led Intellectual Properties, LLC · Jul 2026
5 Wavelength LED Facemask (TN2508)
K260598 · iSMART Developments, Ltd. · Jul 2026
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
K261407 · Dongguan Miqiang Technology Co., Ltd. · Jul 2026