Luxtec MLX Light Source

FDA 510(k) K081477 · Integra Luxtec, Inc.

Substantially Equivalent

510(k) numberK081477

Submission

Device name
Luxtec MLX Light Source
Applicant
Integra Luxtec, Inc.
West Boylston, MA, US
Received
May 27, 2008
Decision date
June 18, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FCW – Light Source, Fiberoptic, Routine
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FCW

510(k)DeviceApplicantDecision
K131226Novaprobe LED Light SourceFCW · Traditional Novaprobe Incorporated07/24/2014SE
K123956Power LED 175FCW · Traditional KARL STORZ Endoscopy-America, Inc.01/25/2013SE
K123359OVS1 Video SystemFCW · Traditional Olive Medical Corp.12/19/2012SE
K121724Endolight LED 1.1 Endolightled 1.2FCW · Traditional Richard Wolf Medical Instruments Corp.09/20/2012SE
K093792LED Light SourceFCW · Traditional Sunoptic Technologies, LLC03/18/2010SE
K091968Karl Storz LED Nova 100 Cold Light Fountain, Models 2016020, 20161020CFCW · Traditional KARL STORZ Endoscopy-America, Inc.09/14/2009SE
K082813Stryker LED LightsourceFCW · Traditional Stryker Corp.12/19/2008SE
K032430Acueity Medical Light SourceFCW · Traditional Acueity, Inc.09/05/2003SE
K012265Metal Halide Light Source, Models MV-9088-T, MV-9088FCW · Traditional Circon Video10/17/2001SE
K000229Videolabs Medcam Proplus Video Camera and Integral Light SourceFCW · Traditional Videolabs, Inc.03/21/2000SE

Questions and answers

When was Luxtec MLX Light Source cleared by the FDA?

Luxtec MLX Light Source (K081477) received a 510(k) decision of Substantially Equivalent on June 18, 2008, 22 days after the submission was received.

What is the product code of K081477?

The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.