Cleared Traditional

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

K231011 · Meridian AG · Ophthalmic

Sep 2023

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K231011 is an FDA 510(k) clearance for the Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Meridian AG (Thun, CH). The FDA issued a Cleared decision on September 12, 2023, 155 days after receiving the submission on April 10, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K231011 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2023
Decision Date	September 12, 2023
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement