Cleared Traditional

K182646 - Vitreq disposable laser probes, light fibers and Chandelier

K182646 is an FDA 510(k) clearance for Vitreq disposable laser probes, manufactured by Vitreq BV. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K182646 · Vitreq BV · Ophthalmic device
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May 2019
Decision
219d
Days
Class 2
Risk

K182646 is an FDA 510(k) clearance for the Vitreq disposable laser probes, light fibers and Chandelier. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Vitreq BV (Vierpolders, NL). The FDA issued a Cleared decision on May 1, 2019 after a review of 219 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 Vitreq BV devices

FDA 510(k) Submission Details - K182646

510(k) Number K182646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date May 01, 2019
Days to Decision 219 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
109d slower than avg
Panel avg: 110d · This submission: 219d
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 Consultant

Beaver-Visitec International, Inc.
Genci Omari

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQB Photocoagulator And Accessories

All 24
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K182646.
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
K220263 · Vortex Surgical, Inc. · Nov 2022
MAXReach Laser Probe
K191846 · Vortex Surgical, Inc. · Dec 2019
PEREGRINE CURVED ILLUMINATING LASER PROBE
K132614 · Peregrine Surgical , Ltd. · Nov 2013
23GA CURVED ILLUMINATING LASER PROBE
K122997 · Peregrine Surgical , Ltd. · Jun 2013
PEREGRINE 23GA CURVED LASER PROBE
K122905 · Peregrine Surgical , Ltd. · Apr 2013
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857 · Synergetics, Inc. · Apr 2012