FDA 510(k)

Endocular Viewing Lenses and Silicone Ring

K-Number: K173944 · 2018-10-25

ApplicantPhakos

Decision Date2018-10-25

Product CodeHJK

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Endocular Viewing Lenses and Silicone Ring is the device name listed in this FDA 510(k) record. The listed applicant is Phakos. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K173944. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endocular Viewing Lenses and Silicone Ring?

Endocular Viewing Lenses and Silicone Ring is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Phakos. The 510(k) number is K173944.

When did Endocular Viewing Lenses and Silicone Ring receive FDA 510(k) clearance?

Endocular Viewing Lenses and Silicone Ring received FDA 510(k) clearance on 2018-10-25, under 510(k) number K173944.

Who is the listed applicant for Endocular Viewing Lenses and Silicone Ring?

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

What is the FDA product code for Endocular Viewing Lenses and Silicone Ring?

The FDA product code for Endocular Viewing Lenses and Silicone Ring is HJK.

Other records listing Phakos 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.

K200911MIRA Adapter K180195Frigitronics adapter K162756PHAKOS Disposable Retinal Cryo Probe

Related Devices (Code: HJK)

K201909RxSight Contact LensRxsight, 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.