Cleared Traditional

Looper (Model: ZX-579S)

K202055 · Heat IN A Click, LLC · General & Plastic Surgery

Apr 2021

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K202055 is an FDA 510(k) clearance for the Looper (Model: ZX-579S), a Over-the-counter Powered Light Based Laser For Acne (Class II — Special Controls, product code OLP), submitted by Heat IN A Click, LLC (Homestead, US). The FDA issued a Cleared decision on April 16, 2021, 266 days after receiving the submission on July 24, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K202055 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2020
Decision Date	April 16, 2021
Days to Decision	266 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.