Cilco Nd:YAG Laser

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

Generic Name

Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary

PMA Number

P840047 ↗

FDA Product Code

LOI

Device Class

Class III

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

• Cilco Villasenor Pachymeter

  Class II

  FDA 510(k) K882805 Active Cleared 12 Aug 1988

• Kratz Nova Sert(Tm)

  Class I

  FDA 510(k) K883489 Active Cleared 25 Oct 1988

• What specific ophthalmic procedures is the CILCO Nd:YAG Laser approved for, and what makes it different from other Nd:YAG lasers on the market?

  The CILCO Nd:YAG Laser is FDA-authorized (PMA P840047) for ophthalmic procedures **excluding** posterior capsulotomy and pupillary cutting. It uses a mode-locked or Q-switched Nd:YAG laser to induce optical breakdown in the posterior capsule or iris, enabling targeted tissue disruption. Unlike some other lasers, this device is explicitly designed for these **limited** applications, as defined by its regulatory classification (product code LOI) and generic name. Always confirm intended use with the manufacturer or local regulations.

• How is the CILCO Nd:YAG Laser supplied, and are there any special handling or storage requirements mentioned in the regulatory data?

  The regulatory data does not specify whether the CILCO Nd:YAG Laser is single-use or reusable, nor does it detail sterility or storage conditions. Since it is classified as a **Class III** medical instrument under FDA_PMA, it may require adherence to standard laser safety protocols and manufacturer guidelines for maintenance. For precise handling instructions—including storage, cleaning, or reprocessing—refer to the device’s labeling or the manufacturer’s instructions for use.

• Is there any information about the regulatory history or timeline for approval of the CILCO Nd:YAG Laser?

  The CILCO Nd:YAG Laser was submitted to the FDA on **September 6, 1985**, with a Federal Register notice published on **September 11, 1985**. It received approval (decision code: APPR) on **November 26, 1985**, under PMA number **P840047**. The advisory committee for ophthalmic devices (OP) reviewed it, and no expedited review was indicated. A supplement (S001) suggests potential future labeling updates, but no additional approvals or changes are noted in the provided data.

• What types of ophthalmic settings or specialties would typically use this laser, and how does its classification impact its use?

  The CILCO Nd:YAG Laser is categorized under **ophthalmic laser systems** (product code LOI) and is intended for use in **ophthalmic settings**, such as clinics or hospitals specializing in procedures like iris surgery or posterior capsule management (excluding capsulotomy). As a **Class III** device under FDA_PMA, it requires strict adherence to regulatory compliance, including proper training for operators and facility protocols. Its approval scope is limited to the uses outlined in the PMA, so clinicians should verify compatibility with their specific procedures.