Cleared Traditional

Shani Darden LED light therapy mask (K214103) - FDA 510(k) Clearance

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

K214103 · Harpar Grace International · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
83d
Days
Class 2
Risk

K214103 is an FDA 510(k) clearance for the Shani Darden LED light therapy mask. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Harpar Grace International (Andover, GB). The FDA issued a Cleared decision on March 22, 2022 after a review of 83 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 Harpar Grace International devices

Submission Details

510(k) Number K214103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2021
Decision Date March 22, 2022
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLP Over-the-counter Powered Light Based Laser For Acne
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
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 - OLP Over-the-counter Powered Light Based Laser For Acne

All 25
Devices cleared under the same product code (OLP) and FDA review panel - the closest regulatory comparables to K214103.
The Luminance RED Acne Device
K220729 · Luminance Medical Ventures, Inc. · Jun 2022
Micro-current facial cold and hot service (model: TPML-100)
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Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
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reVive Light Therapy Essentials
K210968 · Led Technologies, Inc. · Dec 2021
MZ Skin LightMAX Supercharged LED Mask 2.0
K213184 · Mz Skin · Nov 2021
DemarkQ WOW, DemarkQ POP
K203214 · Shenzhen Kaiyan Medical CO , Ltd. · Jul 2021