Cleared Traditional

K100234 - HM-LAMP II

K100234 is an FDA 510(k) clearance for HM-LAMP II, manufactured by Hillusa, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K100234 · Hillusa, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
163d
Days
Class 2
Risk

K100234 is an FDA 510(k) clearance for the HM-LAMP II. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Hillusa, Inc. (Miami, US). The FDA issued a Cleared decision on July 8, 2010 after a review of 163 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.

FDA 510(k) Submission Details - K100234

510(k) Number K100234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date July 08, 2010
Days to Decision 163 days
Submission Type Traditional
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
48d slower than avg
Panel avg: 115d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTD Device Classification - Class 2, Special Controls

Product Code FTD Lamp, Surgical
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 - FTD Lamp, Surgical

All 25
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K100234.
VOLISTA 400
K130513 · Maquet S.A.S. · May 2013
POLARIS 100/200
K123776 · Drager Medical GmbH · Mar 2013
ATRICURE DISSECTOR
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STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp. · Jun 2010
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180 · Engineered Medical Solutions Co., LLC · Jun 2007
HALUX IRIS EXAMINATION AND SURGICAL LAMP
K053364 · Waldmann Lighting · Feb 2006
K100234 · HM-LAMP II
Download PDF FDA Summary Hillusa, Inc.