Cleared Traditional

K251772 - Navilas Laser System 577sl (156691) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K251772 is an FDA 510(k) clearance for the Navilas Laser System 577sl (156691). Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Od-Os GmbH (Teltow, DE). The FDA issued a Cleared decision on October 29, 2025 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Od-Os GmbH devices

Submission Details

510(k) Number K251772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 110d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQF Laser, Ophthalmic

All 179
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