Zirconia Silicate Bead IOL Tumble Polishing

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

Generic Name

intraocular lens

PMA Number

P820016 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002 (Normal 180 Day Track)

• Cystotome, 140-S

  Class I

  FDA 510(k) K840475 Active Cleared 5 Apr 1984

• Cilco I/a Surgical Pack

  Class II

  FDA 510(k) K843319 Active Cleared 14 Feb 1985

• Cilcor Ophthalmic Instruments

  Class I

  FDA 510(k) K843992 Active Cleared 21 Nov 1984

• Cilco Ascan

  Not classified

  FDA 510(k) K827371 Active Cleared 9 Jul 1982

• Octopus 500/500E

  Class I

  FDA 510(k) K841099 Active Cleared 19 Jun 1984

• Opthalmic Endoscope

  Not classified

  FDA 510(k) K832405 Active Cleared 21 Nov 1983

See all devices from Cilco, Inc. →

• What is the primary purpose of the Zirconia Silicate Bead IOL Tumble Polishing system, and how does it improve IOLs during manufacturing?

  The Zirconia Silicate Bead IOL Tumble Polishing system is designed specifically to refine and smooth the surface of intraocular lenses (IOLs) during manufacturing. It uses zirconia silicate beads in a tumble polishing process to enhance optical clarity and precision, ensuring the IOLs meet high standards for consistency and performance before implantation.

• Is this device intended for single-use or reusable applications, and where is it used?

  This device is a reusable polishing apparatus, intended exclusively for controlled manufacturing environments. It is not meant for clinical use with patients but rather for refining IOLs before they are implanted, adhering to sterile processing standards during operation.

• What regulatory pathway does this device follow, and what classification does it hold?

  The Zirconia Silicate Bead IOL Tumble Polishing system is authorized under the FDA’s **Premarket Approval (PMA)** pathway, with PMA number **P820016**. It is classified as a **Class III** device under regulation number **886.3600**, reflecting its role in ensuring precision and safety for intraocular lenses.

• Does this device require any special handling or storage conditions?

  While the device itself is reusable, the polishing process occurs under sterile conditions during manufacturing. There are no explicit storage requirements mentioned for the apparatus itself, but it must be maintained in a clean, controlled environment to ensure consistent performance and compliance with regulatory standards for ophthalmic devices.

• What types of intraocular lenses (IOLs) is this system compatible with, based on the provided data?

  The system is designed for intraocular lenses generally, as indicated by its **generic name** and **OpenFDA device_name** classification. The associated **FEI numbers** and **registration numbers** cover a broad range of IOL models, suggesting compatibility with various types of IOLs used in ophthalmic surgery, though specific lens compatibility should be verified with the manufacturer.