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Zilos-Tk, Version 3, Zilos-Tk, Version 4

by Hamilton Thorne Biosciences

510(k) K050768

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 · Special NumberK050768 Date28 Apr 2005ClearedStatusActive

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  • Withdrawn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
MRX
Device Class
Class II
Regulation
21 CFR Part 884.6200
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Zilos-Tk, Version 3, Zilos-Tk, Version 4 is an Assisted Reproduction Laser System used in human clinical IVF procedures to drill a small tangential hole in or to thin the zona pellucida of the embryo. It is designed for selected in vitro fertilization patients with otherwise poor prognosis for successful pregnancy outcome. The system is used to assist in IVF procedures, particularly for patients with advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida morphology.

The Zilos-Tk system is supplied as a fixed laser system and is intended for use in a clinical setting. It has been cleared under FDA 510(k) with the reference number K050768. The system is classified as a Class 2 device and is regulated under the regulation number 884.6200. It is designed for single-use and is not intended for reuse. The system should be stored according to the manufacturer's instructions and used in accordance with the specified guidelines.

Other devices from Hamilton Thorne Biosciences

Questions

AI-generated answers, 24 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 ZILOS-TK system used for in IVF procedures?

    The ZILOS-TK system is used to drill a small tangential hole in or to thin the zona pellucida of the embryo during in vitro fertilization procedures. It is specifically designed for selected IVF patients with otherwise poor prognosis for successful pregnancy outcome, including those with advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida morphology.

  • How is the ZILOS-TK system supplied and what are its storage requirements?

    The ZILOS-TK system is supplied as a fixed laser system intended for use in a clinical setting. It is designed for single-use and is not intended for reuse. The system should be stored according to the manufacturer's instructions and used in accordance with the specified guidelines to maintain its functionality and safety.

  • What is the regulatory status of the ZILOS-TK system?

    The ZILOS-TK system has been cleared under FDA 510(k) with reference number K050768. It is classified as a Class 2 device and is regulated under regulation number 884.6200. The clearance was granted with a decision code of SESE, indicating it was found to be substantially equivalent to existing devices.

  • Are there different versions of the ZILOS-TK system available?

    Yes, the ZILOS-TK system is available in Version 3 and Version 4. Both versions serve the same purpose of assisting in IVF procedures by drilling holes in or thinning the zona pellucida of embryos for patients with poor pregnancy prognosis.