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FDA 510(k)

HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS

K-Number: K120055 · 2012-04-24

ApplicantHamilton Thorne, Inc.
Decision Date2012-04-24
Product CodeMRX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne, Inc.. It received FDA 510(k) clearance on 2012-04-24 under 510(k) number K120055. 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 HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS?

HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS is a medical device that received FDA 510(k) clearance on 2012-04-24. The listed applicant is Hamilton Thorne, Inc.. The 510(k) number is K120055.

When did HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS receive FDA 510(k) clearance?

HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS received FDA 510(k) clearance on 2012-04-24, under 510(k) number K120055.

Who is the listed applicant for HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS?

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

What is the FDA product code for HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS?

The FDA product code for HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS is MRX.

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Other records listing Hamilton Thorne, 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.

K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)K191552GM501 Mineral OilK190383GM501 Wash

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 GmbHK083208SATURN ACTIVE LASER SYSTEMResearch Instruments , Ltd.K063636ZILOS-TKHamilton Thorne BiosciencesK060764SATURN 3 LASER SYSTEMResearch Instruments , Ltd.

Official Source

View on FDA Database →

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

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