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FDA 510(k)

LipiScan Dynamic Meibomian Imager

K-Number: K182506 · 2018-12-10

ApplicantTearscience, Inc.
Decision Date2018-12-10
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LipiScan Dynamic Meibomian Imager is the device name listed in this FDA 510(k) record. The listed applicant is Tearscience, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K182506. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LipiScan Dynamic Meibomian Imager?

LipiScan Dynamic Meibomian Imager is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Tearscience, Inc.. The 510(k) number is K182506.

When did LipiScan Dynamic Meibomian Imager receive FDA 510(k) clearance?

LipiScan Dynamic Meibomian Imager received FDA 510(k) clearance on 2018-12-10, under 510(k) number K182506.

Who is the listed applicant for LipiScan Dynamic Meibomian Imager?

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

What is the FDA product code for LipiScan Dynamic Meibomian Imager?

The FDA product code for LipiScan Dynamic Meibomian Imager is HKI.

Other records listing Tearscience, 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.

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Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

Official Source

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