Surgical Microscope (OMS2360, OMS2380)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K252464 ↗

FDA Product Code

NBL

FDA applicant

Zumax Medical Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 872.1745

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• OMS2680

  Class I

  CE/MDR

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  Class I

  CE/MDR

• 22-1025

  Class I

  CE/MDR

• OMS3500

  Class I

  CE/MDR

• OMS2650

  Class I

  CE/MDR

• OMS3200

  Class I

  CE/MDR

See all devices from Zumax Medical Co., LTD →

• What types of dental procedures can this microscope assist with, and how does the fluorescence mode benefit the clinician?

  The Surgical Microscope (OMS2360, OMS2380) is designed for high-magnification visualization of oral and dental procedures, making it ideal for tasks requiring precision such as cavity preparation, root canal therapy, or implant placement. The fluorescence mode with a 405nm blue LED light helps detect caries by exciting bacterial activity, allowing clinicians to identify hidden decay more effectively than traditional methods.

• Is this microscope reusable, and if so, what maintenance or cleaning considerations should be noted?

  Yes, the Surgical Microscope (OMS2360, OMS2380) is supplied as a reusable instrument. Since it is intended for clinical use, proper cleaning and sterilization protocols must be followed to ensure hygiene and longevity. The manufacturer’s instructions should be consulted for specific maintenance guidelines, including cleaning agents and procedures to preserve optical clarity and functionality.

• What imaging capabilities does this microscope offer, and how might they enhance clinical workflow?

  The microscope includes integrated 4K imaging with high-speed storage for recording both still images and motion video. This allows clinicians to capture detailed visual documentation of procedures, measure scales directly from images, and zoom in for closer inspection—all of which can improve diagnostic accuracy, support patient education, and streamline case documentation.

• Are there different models available, and if so, how do they differ in terms of features or intended use?

  The Surgical Microscope comes in two models: the OMS2360 and the OMS2380. While the exact differences between them are not specified in the provided data, both are designed for dental surgical procedures with high-magnification visualization and fluorescence capabilities. The models may vary in additional features like ergonomics, accessory compatibility, or software functionalities, so reviewing the manufacturer’s specifications would clarify any distinctions.

• How is this device regulated, and what does the FDA 510(k) clearance indicate about its safety and performance?

  The Surgical Microscope (OMS2360, OMS2380) is authorized under FDA 510(k) clearance, meaning it has been determined to be substantially equivalent to a legally marketed predicate device in terms of technology, performance, and safety. This clearance indicates that the device meets regulatory standards for dental use and has undergone evaluation by the FDA to ensure it does not present unreasonable risks. The MDR (Medical Device Regulation) compliance further supports its adherence to European safety and performance requirements.