MODEL NY-110 FOR UPPER & LOWER - Ny-110 For Upper

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

510(k) Number

K860496 ↗

FDA Product Code

LNK

Models / Variants

Ny-110 For Upper

Lower (Gu)

Pulmonary

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Xanar, Inc. →

• What types of medical procedures is the Model NY-110 laser designed for, and why is it classified as a Class II device?

  The Model NY-110 laser is specifically designed for surgical applications in the upper and lower gastrointestinal tract, genitourinary (GU) system, and pulmonary regions. It uses laser technology to enable precise tissue interaction, which is why it falls under FDA regulation 878.4810 and is classified as a Class II device—requiring more oversight than Class I but not the stringent controls of Class III.

• Is the Model NY-110 laser intended for single-use or reusable applications, and how should it be handled in a clinical setting?

  The Model NY-110 is approved for both single-use and reusable applications in controlled clinical settings. Since no explicit sterility or MRI safety specifications are mentioned, facilities must follow their own validated reprocessing protocols if reusing, ensuring compliance with infection control standards and manufacturer guidelines (if available).

• What regulatory pathway was used for the FDA clearance of this device, and what does ‘Substantially Equivalent’ mean in this context?

  The Model NY-110 received FDA clearance via the Traditional 510(k) review pathway under clearance number K860496, determined to be *Substantially Equivalent* (SESE) to a legally marketed predicate device. This means the FDA found it to have the same intended use and technological characteristics as the predicate, ensuring it meets safety and effectiveness standards without requiring a full pre-market approval.

• How is this laser categorized in terms of medical specialty, and what does the ‘LNK’ product code indicate?

  The Model NY-110 is categorized under the General, Plastic Surgery advisory committee (reviewed by the GU committee) and assigned the product code LNK. This code places it within the broader classification of lasers for surgical applications, though its actual clinical use spans gastroenterology, urology, and pulmonary procedures—not limited to plastic surgery.