Eagle device

FDA 510(k) K230722 · Belkin Vision, Ltd.

Substantially Equivalent

510(k) numberK230722

Submission

Device name
Eagle device
Applicant
Belkin Vision, Ltd.
Yavne, IL
Received
March 16, 2023
Decision date
December 8, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Eagle device cleared by the FDA?

Eagle device (K230722) received a 510(k) decision of Substantially Equivalent on December 8, 2023, 267 days after the submission was received.

What is the product code of K230722?

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