Cleared Traditional

K241933 - HIGHERDOSE Red and Infrared Light Mask ...

K241933 is the FDA 510(k) clearance for HIGHERDOSE Red and Infrared Light Mask ... by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code OHS) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K241933 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
87d
Days
Class 2
Risk

K241933 is an FDA 510(k) clearance for the HIGHERDOSE Red and Infrared Light Mask (MK66-L). Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 27, 2024 after a review of 87 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 Kaiyan Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K241933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2024
Decision Date September 27, 2024
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 119
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K241933.
décoLITE LED Device
K242382 · iSMART Developments, Ltd. · Nov 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
K241718 · Shenzhen Aozemei Technology Co., Ltd. · Oct 2024
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
K241857 · Dongguan Boyuan Intelligent Technology Co.,Ltd · Oct 2024
Luna 4 plus
K241102 · Foreo, Inc. · Aug 2024
PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)
K241203 · Dongguan Hunter Electronic Technology Co., Ltd. · Jul 2024
FAQ™ 201, FAQ™ 202
K240378 · Foreo, Inc. · Apr 2024