Cleared Abbreviated

LaserShot M, NaviLase (K192008) - FDA 510(k) Clearance

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

K192008 · Vitrolife GmbH · Obstetrics & Gynecology device
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Mar 2020
Decision
240d
Days
Class 2
Risk

K192008 is an FDA 510(k) clearance for the LaserShot M, NaviLase. Classified as System, Assisted Reproduction Laser (product code MRX), Class II - Special Controls.

Submitted by Vitrolife GmbH (Bruckberg, DE). The FDA issued a Cleared decision on March 25, 2020 after a review of 240 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6200 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vitrolife GmbH devices

Submission Details

510(k) Number K192008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date March 25, 2020
Days to Decision 240 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 160d · This submission: 240d
Pathway characteristics
Standards-based clearance path.

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.