Cleared Traditional

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) (K253073) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253073 · Sunglor Technology Co., Ltd. · General & Plastic Surgery device
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Nov 2025
Decision
57d
Days
Class 2
Risk

K253073 is an FDA 510(k) clearance for the LED Light Therapy Device (SG-FSM, SG-NK, SG-CT). Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Sunglor Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 19, 2025 after a review of 57 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 Sunglor Technology Co., Ltd. devices

Submission Details

510(k) Number K253073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2025
Decision Date November 19, 2025
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 117
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K253073.
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
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Microcurrent Facial Device (CEC101, EEI101)
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K252053 · Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · Oct 2025
MEGELIN LED Light Therapy Mask (JML1, JML1+JML2)
K252264 · Shenzhen Zhenxing Ruitong Technology Co., Ltd. · Oct 2025