Precisionist Thirty Thousand

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

510(k) Number

K953447 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  Class II

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  FDA 510(k) K970887 Active Cleared 17 Jun 1997

• Phacopak

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• Photon Modular Workstation System, Models Z-12834-X & Z-13175-X

  Class II

  FDA 510(k) K002228 Active Cleared 6 Oct 2000

• Quitetip

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  FDA 510(k) K981109 Active Cleared 9 Jun 1998

See all devices from Paradigm Medical Industries, Inc. →

• What is the Precisionist Thirty Thousand used for?

  The Precisionist Thirty Thousand is a phacofragmentation unit designed for use in ophthalmic procedures and eye surgery applications. It is a Class II medical device that helps surgeons perform specific tasks during eye operations.

• How is the Precisionist Thirty Thousand supplied?

  The device is supplied as a single unit with various model numbers and reference codes as specified in the registration records. It is manufactured by Paradigm Medical Industries, Inc. and comes with the necessary components for ophthalmic procedures.

• What is the regulatory status of the Precisionist Thirty Thousand?

  The Precisionist Thirty Thousand received FDA 510(k) clearance on October 13, 1995, and is registered under product code HQC. It is classified as a Class II medical device and is intended for use in ophthalmic settings with appropriate regulatory oversight.

• Is the Precisionist Thirty Thousand reusable or single-use?

  The device data does not specify whether the Precisionist Thirty Thousand is designed for single-use or multiple uses. The sterilization and reuse policy would depend on the manufacturer's instructions and healthcare facility protocols.