Cleared Traditional

PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT

K230490 · Dongguan Hunter Electronic Technology Co., Ltd. · General & Plastic Surgery

Oct 2023

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K230490 is an FDA 510(k) clearance for the PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT, a Over-the-counter Powered Light Based Laser For Acne (Class II — Special Controls, product code OLP), submitted by Dongguan Hunter Electronic Technology Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on October 27, 2023, 246 days after receiving the submission on February 23, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K230490 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2023
Decision Date	October 27, 2023
Days to Decision	246 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OLP — Over-the-counter Powered Light Based Laser For Acne
Device Class	Class II — 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.