Cleared Traditional

K091064 - NAVILAS LASER SYSTEM

K091064 is an FDA 510(k) clearance for NAVILAS LASER SYSTEM, manufactured by Od-Os GmbH. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K091064 · Od-Os GmbH · Ophthalmic device
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Oct 2009
Decision
196d
Days
Class 2
Risk

K091064 is an FDA 510(k) clearance for the NAVILAS LASER SYSTEM. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Od-Os GmbH (Laguna Beach, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 196 days - an extended review cycle.

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

FDA 510(k) Submission Details - K091064

510(k) Number K091064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2009
Decision Date October 27, 2009
Days to Decision 196 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 110d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

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 86
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