Cleared Traditional

K060764 - SATURN 3 LASER SYSTEM

K060764 is an FDA 510(k) clearance for SATURN 3 LASER SYSTEM, manufactured by Research Instruments , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MRX cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K060764 · Research Instruments , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
356d
Days
Class 2
Risk

K060764 is an FDA 510(k) clearance for the SATURN 3 LASER SYSTEM. Classified as System, Assisted Reproduction Laser (product code MRX), Class II - Special Controls.

Submitted by Research Instruments , Ltd. (Irvine, US). The FDA issued a Cleared decision on March 12, 2007 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K060764

510(k) Number K060764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2006
Decision Date March 12, 2007
Days to Decision 356 days
Submission Type Traditional
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
195d slower than avg
Panel avg: 161d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 10
Devices cleared under the same product code (MRX) and FDA review panel - the closest regulatory comparables to K060764.
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
K120055 · Hamilton Thorne, Inc. · Apr 2012
SATURN ACTIVE LASER SYSTEM
K083208 · Research Instruments , Ltd. · Aug 2009
ZILOS-TK
K063636 · Hamilton Thorne Biosciences · Apr 2007
OCTAX LASER SHOT SYSTEM
K062524 · Minitube of America, Inc. · Dec 2006
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
K050768 · Hamilton Thorne Biosciences · Apr 2005
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
DEN040009 · Hamilton Thorne Biosciences · Nov 2004