CILCO Anterior Chamber Lens

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

510(k) Number

K771933 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• What is the primary purpose of the CILCO Anterior Chamber Lens, and how does it differ from other intraocular lenses?

  The CILCO Anterior Chamber Lens is designed specifically for placement in the anterior chamber of the eye, offering optical correction for patients with cataracts or other conditions requiring lens replacement. Unlike traditional posterior chamber lenses, it avoids implantation in the back of the eye, which may be beneficial for certain clinical scenarios. It is intended for use by trained ophthalmic professionals in surgical settings and is classified as a Class III device under FDA regulations, reflecting its role as an implantable device.

• Is the CILCO Anterior Chamber Lens intended for single-use or reusable applications, and what sterility assurances are provided?

  The CILCO Anterior Chamber Lens is supplied as a single-use, sterile implant. This ensures patient safety by preventing cross-contamination and adhering to best practices for intraocular devices, which are highly sensitive to infection risks. Sterility is a critical requirement for all implants, and the device is manufactured and packaged accordingly to meet regulatory standards.

• What regulatory pathway was followed for FDA clearance of the CILCO Anterior Chamber Lens, and what does this mean for clinicians?

  The CILCO Anterior Chamber Lens received FDA clearance through the 510(k) pathway, specifically under the Traditional Review process with a decision of *Substantially Equivalent* (SESE). This means the device was determined to be as safe and effective as a legally marketed predicate device, ensuring it meets FDA’s standards for intraocular lenses. Clinicians can rely on this clearance as evidence of the device’s regulatory compliance and safety profile for anterior chamber implantation.

• How is the CILCO Anterior Chamber Lens categorized in terms of medical specialty and device classification?

  The CILCO Anterior Chamber Lens is classified under Ophthalmic as its primary medical specialty and falls under FDA Class III, which applies to high-risk devices like intraocular implants. This classification reflects the device’s role in restoring visual function through surgical intervention, requiring stringent regulatory oversight to ensure patient safety and efficacy.