Cleared Special

K140461 - MACH LED 2MC

K140461 is an FDA 510(k) clearance for MACH LED 2MC, manufactured by Dr. Mach GmbH & Co. KG. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Special 510(k) pathway after a 38-day FDA review.

K140461 · Dr. Mach GmbH & Co. KG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
38d
Days
Class 2
Risk

K140461 is an FDA 510(k) clearance for the MACH LED 2MC. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Dr. Mach GmbH & Co. KG (Norderstedt, Schleswig-Holstein, DE). The FDA issued a Cleared decision on April 3, 2014 after a review of 38 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140461

510(k) Number K140461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date April 03, 2014
Days to Decision 38 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

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 Peers - FSY Light, Surgical, Ceiling Mounted

All 67
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K140461.
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