LYNX Photocoagulator

FDA 510(k) K242397 · Norlase Aps

Substantially Equivalent

510(k) numberK242397

Submission

Device name
LYNX Photocoagulator
Applicant
Norlase Aps
Ballerup, DK
Received
August 13, 2024
Decision date
October 25, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HQF – Laser, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4390
Specialty
Ophthalmic

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Questions and answers

When was LYNX Photocoagulator cleared by the FDA?

LYNX Photocoagulator (K242397) received a 510(k) decision of Substantially Equivalent on October 25, 2024, 73 days after the submission was received.

What is the product code of K242397?

The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.