Integra LED Surgical Headlight System

FDA 510(k) K110528 · Integra LifeSciences Corporation

Substantially Equivalent

510(k) numberK110528

Submission

Device name
Integra LED Surgical Headlight System
Applicant
Integra LifeSciences Corporation
York, PA, US
Received
February 24, 2011
Decision date
May 11, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FSR – Light, Headband, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4335
Specialty
Ophthalmic

Other 510(k)s with product code FSR

510(k)DeviceApplicantDecision
K031549Solid State Lamp [Led] HeadlightFSR · Abbreviated Welch Allyn, Inc.08/11/2003SE
K031548LED HeadlightFSR · Abbreviated Welch Allyn, Inc.08/11/2003SE
K994362Headlamp HL2000.FSR · Traditional Angiolaz, Inc.05/11/2000SE

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Questions and answers

When was Integra LED Surgical Headlight System cleared by the FDA?

Integra LED Surgical Headlight System (K110528) received a 510(k) decision of Substantially Equivalent on May 11, 2011, 76 days after the submission was received.

What is the product code of K110528?

The FDA product code is FSR – Light, Headband, Surgical, a Class II (moderate risk) device regulated under 21 CFR 886.4335.