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FDA 510(k)

CureSight-CS100

K-Number: K221375 · 2022-09-29

ApplicantNovasight , Ltd.
Decision Date2022-09-29
Product CodeQQU
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CureSight-CS100 is the device name listed in this FDA 510(k) record. The listed applicant is Novasight , Ltd.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K221375. The device is classified under product code QQU. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CureSight-CS100?

CureSight-CS100 is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Novasight , Ltd.. The 510(k) number is K221375.

When did CureSight-CS100 receive FDA 510(k) clearance?

CureSight-CS100 received FDA 510(k) clearance on 2022-09-29, under 510(k) number K221375.

Who is the listed applicant for CureSight-CS100?

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

What is the FDA product code for CureSight-CS100?

The FDA product code for CureSight-CS100 is QQU.

Related Devices (Code: QQU)

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.

K243819LuminopiaLuminopia, Inc.K233720LuminopiaLuminopia, Inc.K221659Luminopia OneLuminopia, Inc.

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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