Cleared Abbreviated

K123776 - POLARIS 100/200

K123776 is an FDA 510(k) clearance for POLARIS 100/200, manufactured by Drager Medical GmbH. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K123776 · Drager Medical GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
88d
Days
Class 2
Risk

K123776 is an FDA 510(k) clearance for the POLARIS 100/200. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Drager Medical GmbH (Andover, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 88 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K123776

510(k) Number K123776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date March 08, 2013
Days to Decision 88 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

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 K123776.
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
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VOLISTA 400
K130513 · Maquet S.A.S. · May 2013
ATRICURE DISSECTOR
K111020 · AtriCure, Inc. · Jun 2011
HM-LAMP II
K100234 · Hillusa, Inc. · Jul 2010
STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp. · Jun 2010
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180 · Engineered Medical Solutions Co., LLC · Jun 2007
K123776 · POLARIS 100/200
Download PDF FDA Summary Drager Medical GmbH