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MX2-300 Lightsource

by Cuda Products Co. 510(k)

Active United States

510(k) K934337

Overview

The MX2-300 Lightsource is a surgical and endoscopic light device designed to provide illumination during minimally invasive procedures. Classified under product code FSW, it falls under the category of Light, Surgical, Endoscopic devices and is intended for use in general and plastic surgery settings. Its primary function is to enhance visibility within operative fields, ensuring precise manipulation and improved outcomes during endoscopic and surgical interventions.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K934337), granted on November 18, 1993. It adheres to regulation 878.4580 and is classified as a Class II device under special controls. The MX2-300 Lightsource is intended for use in sterile environments and is not MRI-compatible. Storage and handling should follow standard medical device protocols to maintain functionality and sterility.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934337 Date18 Nov 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Cuda Products Corp. Model MX2-300 Lightsource
510(k) Number
FDA Product Code
FSW
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the MX2-300 Lightsource used for?

    The MX2-300 Lightsource is designed to provide illumination during minimally invasive surgical and endoscopic procedures. Its primary purpose is to improve visibility within the operative field, enabling precise manipulation and better outcomes in general and plastic surgery settings.

  • Is the MX2-300 Lightsource reusable or single-use?

    The MX2-300 Lightsource is supplied as a reusable medical instrument. It is intended for repeated use in sterile environments, provided proper cleaning, maintenance, and storage protocols are followed to preserve functionality and sterility.

  • What regulatory approval does the MX2-300 Lightsource hold?

    The MX2-300 Lightsource holds FDA 510(k) clearance under the reference number K934337, granted on November 18, 1993. It is classified as a Class II device under special controls and adheres to regulation 878.4580.

  • Can the MX2-300 Lightsource be used in MRI environments?

    No, the MX2-300 Lightsource is explicitly stated as not MRI-compatible. This means it should not be used in magnetic resonance imaging environments, as it may interfere with or be damaged by MRI fields.

  • How should the MX2-300 Lightsource be stored?

    The MX2-300 Lightsource should be stored and handled according to standard medical device protocols to maintain its functionality and sterility. Since it is reusable, proper cleaning, disinfection, and storage in a clean, dry environment are essential to ensure it remains safe and effective for subsequent uses.