HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)

• K Number: DEN040009
• Device Name: HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
• Manufacturer: HAMILTON THORNE BIOSCIENCES
• Date Cleared: 2004-11-04 ( 71 days)
• Product Code: MRX
• Regulation Number: 884.6200

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 884.6200 Assisted reproduction laser system.

(a)
Identification. The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.

Summary

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