Cleared Traditional

Vitreq disposable laser probes, light fibers and Chandelier (K182646) - FDA 510(k) Clearance

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

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

Submission Details

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.

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.

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.