Cleared Traditional

MIIN (K193266) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193266 · Medico USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
423d
Days
Class 2
Risk

K193266 is an FDA 510(k) clearance for the MIIN. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Medico USA, Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 22, 2021 after a review of 423 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

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 Medico USA, Inc. devices

Submission Details

510(k) Number K193266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2019
Decision Date January 22, 2021
Days to Decision 423 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 115d · This submission: 423d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - 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.
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 Consultant

Provision Consulting Group, Inc.
Joyce Kwon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 536
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K193266.
Laser Treatment System, Model: NYX and Grace
K210033 · Canadian Pioneer Medical Technology Corporation · Feb 2021
Global Med Systems Milesman Compact Laser
K203804 · Global Med Systems SL · Feb 2021
Rapid Acoustic Pulse Device
K201801 · Soliton, Inc. · Jan 2021
OmniGuide BeamPath OTO-U Fiber
K203241 · Omniguide, Inc. · Jan 2021
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
K203544 · Lumenis, Ltd. · Dec 2020
Primelase Excellence
K201594 · High Technology Products S.L.U · Dec 2020