Cleared Special

LION Photocoagulator

K201623 · Norlase Aps · Ophthalmic

Aug 2020

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K201623 is an FDA 510(k) clearance for the LION Photocoagulator, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Norlase Aps (2750 Ballerup, DK). The FDA issued a Cleared decision on August 11, 2020, 57 days after receiving the submission on June 15, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K201623 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2020
Decision Date	August 11, 2020
Days to Decision	57 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF