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FDA 510(k)

SATURN ACTIVE LASER SYSTEM

K-Number: K083208 · 2009-08-25

ApplicantResearch Instruments , Ltd.
Decision Date2009-08-25
Product CodeMRX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SATURN ACTIVE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Research Instruments , Ltd.. It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K083208. The device is classified under product code MRX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATURN ACTIVE LASER SYSTEM?

SATURN ACTIVE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Research Instruments , Ltd.. The 510(k) number is K083208.

When did SATURN ACTIVE LASER SYSTEM receive FDA 510(k) clearance?

SATURN ACTIVE LASER SYSTEM received FDA 510(k) clearance on 2009-08-25, under 510(k) number K083208.

Who is the listed applicant for SATURN ACTIVE LASER SYSTEM?

The FDA 510(k) record lists Research Instruments , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SATURN ACTIVE LASER SYSTEM?

The FDA product code for SATURN ACTIVE LASER SYSTEM is MRX.

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Other records listing Research Instruments , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112413RI MSC (MIGRATION SEDIMENTATION CHAMBER)K060764SATURN 3 LASER SYSTEMK003142MICROMANIPULATORK991261ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET

Related Devices (Code: MRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253333Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd.K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc.K192008LaserShot M, NaviLaseVitrolife GmbHK120055HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOSHamilton Thorne, Inc.K063636ZILOS-TKHamilton Thorne BiosciencesK060764SATURN 3 LASER SYSTEMResearch Instruments , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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