FDA 510(k)

LYNX Photocoagulator

K-Number: K242397 · 2024-10-25

Decision Date2024-10-25

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

LYNX Photocoagulator is the device name listed in this FDA 510(k) record. The listed applicant is Norlase Aps. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K242397. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYNX Photocoagulator?

LYNX Photocoagulator is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Norlase Aps. The 510(k) number is K242397.

When did LYNX Photocoagulator receive FDA 510(k) clearance?

LYNX Photocoagulator received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242397.

Who is the listed applicant for LYNX Photocoagulator?

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

What is the FDA product code for LYNX Photocoagulator?

The FDA product code for LYNX Photocoagulator is HQF.

Other records listing Norlase Aps 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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Official Source

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