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FDA 510(k)

LO-50 LED LIGHT SOURCE

K-Number: K102167 · 2010-08-17

ApplicantFiberoptics Technology, Inc.
Decision Date2010-08-17
Product CodeNTN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LO-50 LED LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptics Technology, Inc.. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K102167. The device is classified under product code NTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LO-50 LED LIGHT SOURCE?

LO-50 LED LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Fiberoptics Technology, Inc.. The 510(k) number is K102167.

When did LO-50 LED LIGHT SOURCE receive FDA 510(k) clearance?

LO-50 LED LIGHT SOURCE received FDA 510(k) clearance on 2010-08-17, under 510(k) number K102167.

Who is the listed applicant for LO-50 LED LIGHT SOURCE?

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

What is the FDA product code for LO-50 LED LIGHT SOURCE?

The FDA product code for LO-50 LED LIGHT SOURCE is NTN.

Related Clinical Trials

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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Other records listing Fiberoptics Technology, 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.

K904378F.T.I. MEDICAL LIGHT GUIDE

Related Devices (Code: NTN)

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.

K130819CLL- V1 LIGHT SOURCEOlympus Winter & Ibe GmbHK122831VIDEO SYSTEM CENTEROlympus Medical Systems Corp.K113679LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.K103813SOPRO 281SoproK091829PLS PORTABLE LIGHT SOURCEOptim, Inc.K090601FSC 2Schoelly Imaging, Inc.

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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