Cleared Traditional

LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001

K230720 · Light Tree Ventures Europe B.V. · General & Plastic Surgery

Jul 2023

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K230720 is an FDA 510(k) clearance for the LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001, a Over-the-counter Powered Light Based Laser For Acne (Class II — Special Controls, product code OLP), submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on July 3, 2023, 109 days after receiving the submission on March 16, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K230720 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2023
Decision Date	July 03, 2023
Days to Decision	109 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.