FDA 510(k)

INFINITT ULite

K-Number: K163290 · 2017-03-24

Decision Date2017-03-24

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

INFINITT ULite is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Co., Ltd.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K163290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITT ULite?

INFINITT ULite is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Infinitt Co., Ltd.. The 510(k) number is K163290.

When did INFINITT ULite receive FDA 510(k) clearance?

INFINITT ULite received FDA 510(k) clearance on 2017-03-24, under 510(k) number K163290.

Who is the listed applicant for INFINITT ULite?

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

What is the FDA product code for INFINITT ULite?

The FDA product code for INFINITT ULite is LLZ.

Related Devices (Code: LLZ)

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.

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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.