Cleared Traditional

K191846 - MAXReach Laser Probe

K191846 is an FDA 510(k) clearance for MAXReach Laser Probe, manufactured by Vortex Surgical, Inc.. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 166-day FDA review.

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

FDA 510(k) Submission Details - K191846

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
Combination Product No
PCCP Authorized No
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.

HQB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HQB Photocoagulator And Accessories

All 15
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K191846.
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
K220263 · Vortex Surgical, Inc. · Nov 2022
Vitreq disposable laser probes, light fibers and Chandelier
K182646 · Vitreq BV · May 2019
ZIESS ENDOPROBE
K922735 · Carl Zeiss, Inc. · Jul 1992
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679 · Surgical Laser Technologies, Inc. · Dec 1988
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
K882441 · Surgical Laser Technologies, Inc. · Sep 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · Advanced Surgical Products, Inc. · Jun 1988