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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 a medical device manufactured by Novasight , Ltd.. It received FDA 510(k) clearance on 2022-09-29 under approval 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. It is manufactured by Novasight , Ltd.. The 510(k) number is K221375.

When was CureSight-CS100 approved by the FDA?

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

What company makes CureSight-CS100?

CureSight-CS100 is manufactured by Novasight , Ltd..

What is the FDA product code for CureSight-CS100?

The FDA product code for CureSight-CS100 is QQU.

Related Devices (Code: QQU)

DEN210005Luminopia OneLuminopia, Inc. K221659Luminopia OneLuminopia, Inc. K233720LuminopiaLuminopia, Inc. K243819LuminopiaLuminopia, 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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