Cleared Traditional

K002463 - STELLAR

K002463 is an FDA 510(k) clearance for STELLAR, manufactured by Skytron, Div. the Kmw Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002463 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
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Nov 2000
Decision
90d
Days
Class 2
Risk

K002463 is an FDA 510(k) clearance for the STELLAR. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K002463

510(k) Number K002463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2000
Decision Date November 08, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 73
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K002463.
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · Skytron, Div. the Kmw Group, Inc. · Nov 2002
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
K011693 · Trumpf Medical Systems, Inc. · Jun 2001
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
K010716 · Valmed Corp. · May 2001
VISIONARY 2000
K000639 · Burton Medical Products Corp. · May 2000
CASTLE SURGICAL LIGHT, MODEL 3000
K993242 · Getinge/Castle, Inc. · Nov 1999
MILLENNIUM GOLD
K992090 · Skytron, Div. the Kmw Group, Inc. · Sep 1999
K002463 · STELLAR
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