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FDA 510(k)

OCTAX LASER SHOT SYSTEM

K-Number: K062524 · 2006-12-15

ApplicantMinitube of America, Inc.
Decision Date2006-12-15
Product CodeMRX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OCTAX LASER SHOT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Minitube of America, Inc.. It received FDA 510(k) clearance on 2006-12-15 under 510(k) number K062524. 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 OCTAX LASER SHOT SYSTEM?

OCTAX LASER SHOT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-15. The listed applicant is Minitube of America, Inc.. The 510(k) number is K062524.

When did OCTAX LASER SHOT SYSTEM receive FDA 510(k) clearance?

OCTAX LASER SHOT SYSTEM received FDA 510(k) clearance on 2006-12-15, under 510(k) number K062524.

Who is the listed applicant for OCTAX LASER SHOT SYSTEM?

The FDA 510(k) record lists Minitube of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTAX LASER SHOT SYSTEM?

The FDA product code for OCTAX LASER SHOT SYSTEM is MRX.

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Other records listing Minitube of America, Inc. 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.

K050197MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

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.K083208SATURN ACTIVE LASER SYSTEMResearch Instruments , Ltd.K063636ZILOS-TKHamilton Thorne Biosciences

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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