Cleared Abbreviated

K192008 - LaserShot M, NaviLase

K192008 is an FDA 510(k) clearance for LaserShot M, manufactured by Vitrolife GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code MRX cleared through the Abbreviated 510(k) pathway after a 240-day FDA review.

K192008 · Vitrolife GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K192008

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.

MRX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MRX System, Assisted Reproduction Laser

All 8
Devices cleared under the same product code (MRX) and FDA review panel - the closest regulatory comparables to K192008.
Assisted Reproduction Laser System (Model ILS-400M)
K253333 · Hua Yue Medical Technology Co., Ltd. · Jun 2026
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
K202241 · Hamilton Thorne, Inc. · Jul 2021
SATURN 5 LASER
K141434 · Research Instruments , Ltd. · Feb 2015
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
K120055 · Hamilton Thorne, Inc. · Apr 2012
ZILOS-TK
K063636 · Hamilton Thorne Biosciences · Apr 2007
SATURN 3 LASER SYSTEM
K060764 · Research Instruments , Ltd. · Mar 2007