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FDA 510(k)

IllumiFlow Laser Cap

K-Number: K162071 · 2017-02-24

ApplicantEglobal, LLC
Decision Date2017-02-24
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IllumiFlow Laser Cap is the device name listed in this FDA 510(k) record. The listed applicant is Eglobal, LLC. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162071. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IllumiFlow Laser Cap?

IllumiFlow Laser Cap is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Eglobal, LLC. The 510(k) number is K162071.

When did IllumiFlow Laser Cap receive FDA 510(k) clearance?

IllumiFlow Laser Cap received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162071.

Who is the listed applicant for IllumiFlow Laser Cap?

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

What is the FDA product code for IllumiFlow Laser Cap?

The FDA product code for IllumiFlow Laser Cap is OAP.

Other records listing Eglobal, LLC 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.

Related Devices (Code: OAP)

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.

Official Source

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