Cleared Special

K231952 - MEDILIGHT (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231952 · Medicreations, LLC · General & Plastic Surgery device
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Sep 2025
Decision
796d
Days
Class 2
Risk

K231952 is an FDA 510(k) clearance for the MEDILIGHT. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Medicreations, LLC (Las Vegas, US). The FDA issued a Cleared decision on September 3, 2025 after a review of 796 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Medicreations, LLC devices

Submission Details

510(k) Number K231952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
682d slower than avg
Panel avg: 114d · This submission: 796d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect

All 72
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