Cleared Traditional

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. · General & Plastic Surgery

Jul 2024

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K241203 is an FDA 510(k) clearance for the 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), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Dongguan Hunter Electronic Technology Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on July 25, 2024, 86 days after receiving the submission on April 30, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K241203 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2024
Decision Date	July 25, 2024
Days to Decision	86 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OHS — Light Based Over The Counter Wrinkle Reduction
Device Class	Class II — 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.