Skip to content

Phacoilluminator - Fiberoptic Sleeve

by Michael Reynard, M.D.

510(k) K964018

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964018 Date26 Feb 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Phacoilluminator - Fiberoptic Sleeve is a fiberoptic device designed for use during phacofragmentation procedures in ophthalmic surgery. It provides illumination at the surgical site by transmitting light through a clear silicone sleeve, enhancing visibility for precise cataract removal.

This device is intended for single-use in sterile surgical environments and is classified as a Class II medical device under FDA regulations. Supplied as a sterile sleeve, it is compatible with phacoemulsification systems and requires proper storage to maintain sterility. The device holds an FDA 510(k) clearance (K964018) and is regulated under the applicable ophthalmic surgical standards.

Other devices from Michael Reynard, M.D.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Phacoilluminator - Fiberoptic Sleeve in cataract surgery?

    The Phacoilluminator - Fiberoptic Sleeve is designed to enhance visibility during phacofragmentation procedures by transmitting light through a clear silicone sleeve. This illumination helps surgeons achieve greater precision when removing cataracts, improving the clarity of the surgical field.

  • Is the Phacoilluminator - Fiberoptic Sleeve intended for reuse or single-use?

    The device is explicitly intended for single-use only in sterile surgical environments. This ensures patient safety and maintains sterility standards for each procedure.

  • How should the Phacoilluminator - Fiberoptic Sleeve be stored to preserve its sterility?

    Since it is supplied as a sterile sleeve, proper storage conditions—such as keeping it in its original packaging, away from moisture, and protecting it from contamination—are critical to maintain sterility before use.

  • What compatibility considerations should be taken when using this device with phacoemulsification systems?

    The Phacoilluminator - Fiberoptic Sleeve is compatible with phacoemulsification systems, but compatibility may depend on the specific system’s fiberoptic interface. Always verify compatibility with your equipment manufacturer’s guidelines to ensure proper integration and functionality.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The Phacoilluminator - Fiberoptic Sleeve received FDA 510(k) clearance (K964018) under the Traditional pathway, with a decision date of February 26, 1997. It was classified as a Class II medical device and determined to be substantially equivalent to a predicate device under ophthalmic surgical standards.