Device (20-Ch W +2 more) - 20-Ch W

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894241 ↗

FDA Product Code

GEX

Models / Variants

20-Ch W

Ar-10A

U Optical Attachment

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Carbon Dioxide Laser System Model 20-Cx W/Attach.

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  FDA 510(k) K883738 Active Cleared 15 Nov 1988

• Model 8-B with La-2B Attachment for Ob-Gyn Use

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  FDA 510(k) K861845 Active Cleared 11 Aug 1986

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• Model 8-B with Os-1 Attachment (C02 Laser for ENT)

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  FDA 510(k) K862150 Active Cleared 4 Sep 1986

• Model 20-B W/Ob-10A/U Attach. for Ear, Nose/Throat

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  FDA 510(k) K872710 Active Cleared 24 Sep 1987

• Model 8-B CO2 Laser for General & Plastic Surgery

  Class II

  FDA 510(k) K862423 Active Cleared 15 Sep 1986

See all devices from Directed Energy, Inc. →

• What is the Model 20-CH with AR-10A/U Optical Attachment used for?

  This device is designed to interface with arthroscopic surgical systems and laser diode drivers, allowing precise transmission of laser energy through a 20-channel optical fiber bundle. It supports minimally invasive surgical techniques in general and plastic surgery settings, enhancing procedural accuracy by delivering focused laser energy where needed.

• Is the Model 20-CH with AR-10A/U Optical Attachment reusable or single-use?

  The device is supplied as a reusable component, intended for use in sterile surgical environments. Proper handling, cleaning, and maintenance are required to ensure its functionality and sterility between procedures. Reusability is contingent on adherence to manufacturer guidelines for decontamination and storage.

• Can this optical attachment be used in MRI environments?

  No, this device is explicitly not intended for use in MRI environments. The optical attachment is designed for surgical settings where MRI compatibility is not required, and its materials or construction may not meet MRI safety standards. Always verify the surgical environment’s compatibility before use.

• What sizes or models are available for this optical attachment?

  This specific model is the Model 20-CH with AR-10A/U Optical Attachment, characterized by its 20-channel optical fiber bundle. Directed Energy, Inc. may offer variations in channel configurations or attachments, but this particular model is distinguished by its 20-channel design and compatibility with arthroscopic laser systems. For alternative models, consult the manufacturer’s product catalog.

• How should the Model 20-CH with AR-10A/U Optical Attachment be stored?

  The device should be stored in a clean, dry environment protected from physical damage, moisture, or contamination. Since it is reusable, storage should follow manufacturer-recommended protocols to maintain sterility and functionality. Avoid exposure to extreme temperatures or direct sunlight, and ensure it is securely packaged when not in use to prevent accidental damage or misplacement.