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FDA 510(k)

InnerView LC

K-Number: K232657 · 2023-09-01

ApplicantPerimetrics, Inc.
Decision Date2023-09-01
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

InnerView LC is the device name listed in this FDA 510(k) record. The listed applicant is Perimetrics, Inc.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232657. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InnerView LC?

InnerView LC is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Perimetrics, Inc.. The 510(k) number is K232657.

When did InnerView LC receive FDA 510(k) clearance?

InnerView LC received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232657.

Who is the listed applicant for InnerView LC?

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

What is the FDA product code for InnerView LC?

The FDA product code for InnerView LC is EKX.

Other records listing Perimetrics, 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.

K251597InnerView System

Related Devices (Code: EKX)

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.

K252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.K243911HPR Cordless Hygiene HandpieceHandpiece Headquarters

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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