Cleared Traditional

K191846 - MAXReach Laser Probe (FDA 510(k) Clearance)

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

K191846 · Vortex Surgical, Inc. · Ophthalmic device
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Dec 2019
Decision
166d
Days
Class 2
Risk

K191846 is an FDA 510(k) clearance for the MAXReach Laser Probe. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Vortex Surgical, Inc. (Chesterfield, US). The FDA issued a Cleared decision on December 23, 2019 after a review of 166 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - 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 Vortex Surgical, Inc. devices

Submission Details

510(k) Number K191846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2019
Decision Date December 23, 2019
Days to Decision 166 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
56d slower than avg
Panel avg: 110d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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.