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FDA 510(k)

LenSx Laser System (8065998162)

K-Number: K243896 · 2025-04-28

ApplicantAlcon Laboratories, Inc.
Decision Date2025-04-28
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LenSx Laser System (8065998162) is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2025-04-28 under 510(k) number K243896. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LenSx Laser System (8065998162)?

LenSx Laser System (8065998162) is a medical device that received FDA 510(k) clearance on 2025-04-28. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K243896.

When did LenSx Laser System (8065998162) receive FDA 510(k) clearance?

LenSx Laser System (8065998162) received FDA 510(k) clearance on 2025-04-28, under 510(k) number K243896.

Who is the listed applicant for LenSx Laser System (8065998162)?

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

What is the FDA product code for LenSx Laser System (8065998162)?

The FDA product code for LenSx Laser System (8065998162) is OOE.

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Related Devices (Code: OOE)

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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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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