Cleared Traditional

Navilas Laser System 577sl (156691)

K251772 · Od-Os GmbH · Ophthalmic
Oct 2025
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K251772 is an FDA 510(k) clearance for the Navilas Laser System 577sl (156691), a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Od-Os GmbH (Teltow, DE). The FDA issued a Cleared decision on October 29, 2025, 141 days after receiving the submission on June 10, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K251772 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2025
Decision Date October 29, 2025
Days to Decision 141 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390