Cleared Special

MEDILIGHT

K231952 · Medicreations, LLC · General & Plastic Surgery

Sep 2025

Decision

796d

Days

Class 2

Risk

About This 510(k) Submission

K231952 is an FDA 510(k) clearance for the MEDILIGHT, a Powered Light Based Non-laser Surgical Instrument With Thermal Effect (Class II — Special Controls, product code ONF), submitted by Medicreations, LLC (Las Vegas, US). The FDA issued a Cleared decision on September 3, 2025, 796 days after receiving the submission on June 30, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K231952 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2023
Decision Date	September 03, 2025
Days to Decision	796 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	ONF — Powered Light Based Non-laser Surgical Instrument With Thermal Effect
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	A Light Based Non-laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (ipl). Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic. Indication For Use Can Be General And/or Specific.the Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Or Remove Tissue By The Light.