LION Photocoagulator

FDA 510(k) K201623 · Norlase Aps

Substantially Equivalent

510(k) numberK201623

Submission

Device name
LION Photocoagulator
Applicant
Norlase Aps
2750 Ballerup, DK
Received
June 15, 2020
Decision date
August 11, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 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 LION Photocoagulator cleared by the FDA?

LION Photocoagulator (K201623) received a 510(k) decision of Substantially Equivalent on August 11, 2020, 57 days after the submission was received.

What is the product code of K201623?

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