B100 Disposable Handpiece

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K894762 ↗

FDA Product Code

HAM

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Beacon Laboratories, Inc. →

• What types of surgical procedures is the B100 Disposable Handpiece designed for, and how does it function in those settings?

  The B100 Disposable Handpiece is designed for use in general and plastic surgery procedures. It is intended to be paired with electrosurgical systems to perform tissue cutting, coagulation, or desiccation in controlled surgical environments. Its single-use, sterile design ensures safety and consistency during delicate procedures where precision is critical.

• Is the B100 Disposable Handpiece reusable, or is it meant for one-time use only? How does this affect its handling and storage?

  The B100 Disposable Handpiece is explicitly designed for single-use only, meaning it must not be reused after a single surgical procedure. This design ensures sterility and reduces the risk of contamination. As a disposable unit, it must be stored according to the manufacturer’s guidelines prior to use, typically in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.

• What regulatory pathway was followed for FDA clearance of the B100 Disposable Handpiece, and what does this mean for its use in clinical settings?

  The B100 Disposable Handpiece received FDA clearance through the Traditional 510(k) pathway under the classification of an Apparatus, Electrosurgical (HAM). This means it was determined to be substantially equivalent to a legally marketed device already on the market. Clinically, this clearance confirms its compliance with FDA standards for electrosurgical handpieces, ensuring it meets safety and performance requirements for use in surgical settings without requiring third-party certification.

• Are there multiple model numbers for the B100 Disposable Handpiece, and how can I identify the correct one for my procedure?

  Yes, the B100 Disposable Handpiece comes in multiple model variants, each uniquely identifiable by its model number (listed in the provided registration numbers). While the core function remains the same—electrosurgical cutting, coagulation, or desiccation—the specific model may vary in minor design features or compatibility with certain electrosurgical systems. Always verify the model number on the packaging against your surgical system’s requirements to ensure proper fit and function.

• How should the B100 Disposable Handpiece be stored before use, and what precautions should be taken to maintain its sterility?

  The B100 Disposable Handpiece is supplied as a sterile unit, so it must be stored in its original, unopened packaging until ready for use. Storage should follow the manufacturer’s guidelines, typically in a clean, dry area protected from moisture, dust, and extreme temperatures. Avoid exposing it to direct sunlight or sources of contamination, as this could compromise its sterility and performance. Once opened, it should be used immediately in a controlled surgical environment.