Cleared Abbreviated

K083208 - SATURN ACTIVE LASER SYSTEM (FDA 510(k) Clearance)

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

K083208 · Research Instruments , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
298d
Days
Class 2
Risk

K083208 is an FDA 510(k) clearance for the SATURN ACTIVE LASER SYSTEM. Classified as System, Assisted Reproduction Laser (product code MRX), Class II - Special Controls.

Submitted by Research Instruments , Ltd. (Falmouth, Cornwall, GB). The FDA issued a Cleared decision on August 25, 2009 after a review of 298 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 Research Instruments , Ltd. devices

Submission Details

510(k) Number K083208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2008
Decision Date August 25, 2009
Days to Decision 298 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 160d · This submission: 298d
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.