Cleared Traditional

K093009 - MACH LED SC

K093009 is an FDA 510(k) clearance for MACH LED SC, manufactured by Dr. Mach GmbH & Co. KG. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K093009 · Dr. Mach GmbH & Co. KG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
184d
Days
Class 2
Risk

K093009 is an FDA 510(k) clearance for the MACH LED SC. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Dr. Mach GmbH & Co. KG (Ebersberg, DE). The FDA issued a Cleared decision on April 1, 2010 after a review of 184 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dr. Mach GmbH & Co. KG devices

FDA 510(k) Submission Details - K093009

510(k) Number K093009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date April 01, 2010
Days to Decision 184 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 115d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 19
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K093009.
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
AURORA LED SERIES SURGICAL LIGHTS
K071698 · Skytron, Div. the Kmw Group, Inc. · Jul 2007
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · Stryker Endoscopy · Aug 2003
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · Skytron, Div. the Kmw Group, Inc. · Nov 2002
STELLAR
K002463 · Skytron, Div. the Kmw Group, Inc. · Nov 2000
MILLENNIUM GOLD
K992090 · Skytron, Div. the Kmw Group, Inc. · Sep 1999