Cleared Special

K231950 - MEDIDIODE
(FDA 510(k) Clearance)

K231950 · Medicreations, LLC · General & Plastic Surgery

Aug 2024

Decision

406d

Days

Class 2

Risk

K231950 is an FDA 510(k) clearance for the MEDIDIODE, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Medicreations, LLC (Las Vegas, US). The FDA issued a Cleared decision on August 9, 2024, 406 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	K231950 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2023
Decision Date	August 09, 2024
Days to Decision	406 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	GEX — Powered Laser Surgical Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.