Not Cleared Post-NSE

DEN040009 - HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN040009 · Hamilton Thorne Biosciences · Obstetrics & Gynecology device
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Nov 2004
Decision
71d
Days
Class 2
Risk

DEN040009 is an FDA 510(k) submission (not cleared) for the HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK). Classified as System, Assisted Reproduction Laser (product code MRX), Class II - Special Controls.

Submitted by Hamilton Thorne Biosciences (Beverly, US). The FDA issued a Not Cleared (DENG) decision on November 4, 2004 after a review of 71 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6200 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Obstetrics & Gynecology review framework.

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Submission Details

510(k) Number DEN040009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 25, 2004
Decision Date November 04, 2004
Days to Decision 71 days
Submission Type Post-NSE
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 160d · This submission: 71d
Pathway characteristics

Device Classification

Product Code MRX System, Assisted Reproduction Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6200
Definition This System Is Inteded To Be Used To Drill A Small Tangential Hole In Or To Thin The Zona Pellucida Of The Embryo In Selected In Vitro Fertilization Patients With Otherwise Poor Prognois For Successful Pregnancy Outcome, Such As Advanced Maternal Age, Prior Failed In Vitro Fertilization Procedures, Cryopreserved Embryos, Or Abnormal Zona Pellucida Morphology.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.