Cleared Abbreviated

K160531 - Noiselezz

K160531 is an FDA 510(k) clearance for Noiselezz, manufactured by Firma Ingemarsson. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 189-day FDA review.

K160531 · Firma Ingemarsson · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
189d
Days
Class 2
Risk

K160531 is an FDA 510(k) clearance for the Noiselezz. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Firma Ingemarsson (Charlottenlund, DK). The FDA issued a Cleared decision on September 1, 2016 after a review of 189 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K160531

510(k) Number K160531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2016
Decision Date September 01, 2016
Days to Decision 189 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 128d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 Dental devices follow this clearance model.

Regulatory Consultant

Danish Medical Devices Consulting Aps
Poul Schmidt-Andersen

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 - LRK Device, Anti-snoring

All 207
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