Model 10-C W/ SA-10A/U Optical Attachment/Surg Use

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K870838 ↗

FDA Product Code

GEX

Models / Variants

10-C W

SA-10A

U Optical Attachment

Surg Use

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.

  Class II

  FDA 510(k) K883738 Active Cleared 15 Nov 1988

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  FDA 510(k) K862422 Active Cleared 2 Oct 1986

• 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-Ch W/ Ar-10A/U Optical Attachment

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  FDA 510(k) K894241 Active Cleared 18 Jun 1990

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

  Class II

  FDA 510(k) K872710 Active Cleared 24 Sep 1987

See all devices from Directed Energy, Inc. →

• Is this optical attachment designed for single-use or can it be reused in multiple procedures?

  This device, the Model 10-C with SA-10A/U Optical Attachment, is explicitly described as a reusable component for surgical use. Since it is not labeled as single-use, it must be properly sterilized and maintained per the manufacturer’s guidelines between uses to ensure safety and performance. Always follow Directed Energy, Inc.’s instructions to avoid cross-contamination or degradation.

• How is this device intended to be used in the operating room, and what type of laser system does it pair with?

  The Model 10-C with SA-10A/U Optical Attachment is designed to interface with an existing laser system rather than being used standalone. It delivers precise optical energy for tissue ablation or coagulation during general and plastic surgery procedures. The attachment’s construction ensures controlled energy application, making it suitable for surgical environments where laser precision is critical.

• What regulatory pathway was followed for FDA clearance, and when was the decision made?

  The Model 10-C with SA-10A/U Optical Attachment received FDA 510(k) clearance under the Traditional review pathway, with a decision date of May 26, 1987. The clearance was granted as substantially equivalent (SESE) to a predicate device, as indicated in the regulatory filing. This means the device met FDA standards for safety and effectiveness at the time of approval.

• Are there any special storage or handling instructions for this reusable device?

  Since this is a reusable component, it must be stored and handled according to Directed Energy, Inc.’s guidelines to maintain sterility and functionality. While the data does not specify exact storage conditions, proper cleaning, sterilization, and maintenance are required between uses to prevent damage or contamination. Always refer to the manufacturer’s instructions for detailed protocols.

• What types of surgical procedures is this optical attachment commonly used for?

  The Model 10-C with SA-10A/U Optical Attachment is classified under product code GEX, which corresponds to general and plastic surgery procedures. While the exact clinical applications are not detailed, its design suggests it is intended for tissue ablation or coagulation tasks where precise laser energy delivery is required, such as in dermatological, reconstructive, or cosmetic surgeries.