Cleared Traditional

Leos Laser and Endoscopy System

K240615 · Beaver-Visitec International, Inc. · Ophthalmic

Apr 2025

Decision

394d

Days

Class 2

Risk

About This 510(k) Submission

K240615 is an FDA 510(k) clearance for the Leos Laser and Endoscopy System, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Beaver-Visitec International, Inc. (Waltham, US). The FDA issued a Cleared decision on April 3, 2025, 394 days after receiving the submission on March 5, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K240615 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2024
Decision Date	April 03, 2025
Days to Decision	394 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF