Cleared Traditional

K220519 - Erchonia Zerona Z-Bed

K220519 is the FDA 510(k) clearance for Erchonia Zerona Z-Bed by Erchonia Corporation. It is a Class 2 General & Plastic Surgery device (product code OLI) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K220519 · Erchonia Corporation · General & Plastic Surgery device
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Mar 2022
Decision
29d
Days
Class 2
Risk

K220519 is an FDA 510(k) clearance for the Erchonia Zerona Z-Bed. Classified as Fat Reducing Low Level Laser within the OLI classification (a category for non-invasive low-level laser body contouring systems), Class II - Special Controls.

Submitted by Erchonia Corporation (Melbourne, US). The FDA issued a Cleared decision on March 24, 2022 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Erchonia Corporation devices

Submission Details

510(k) Number K220519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2022
Decision Date March 24, 2022
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code OLI Fat Reducing Low Level Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5400
Definition Non-invasive Reduction In Fat Layer For Body Contouring
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 - OLI Fat Reducing Low Level Laser

All 14
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Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.