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)
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.

View all Hillusa, Inc. devices

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
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 11
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K100234.
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ATRICURE DISSECTOR
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K981717 · Stryker Instruments · Jun 1998
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996