Cleared Traditional

K142984 - Leo Minor

K142984 is an FDA 510(k) clearance for Leo Minor, manufactured by Sunnex, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K142984 · Sunnex, Inc. · General & Plastic Surgery device
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Oct 2014
Decision
13d
Days
Class 2
Risk

K142984 is an FDA 510(k) clearance for the Leo Minor. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Sunnex, Inc. (Charlotte, US). The FDA issued a Cleared decision on October 29, 2014 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 Sunnex, Inc. devices

FDA 510(k) Submission Details - K142984

510(k) Number K142984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2014
Decision Date October 29, 2014
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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
MARK JOB

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 - FSY Light, Surgical, Ceiling Mounted

All 53
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K142984.
CLAVEGUARD FREEDOM SURGICAL LIGHT
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K140460 · Dr. Mach GmbH & Co. KG · Apr 2014
MACH LED 2MC
K140461 · Dr. Mach GmbH & Co. KG · Apr 2014

FDA 510(k) Resources - General & Plastic Surgery

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