510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110528Substantially Equivalent

Integra LED Surgical Headlight System

Integra LifeSciences Corporation, York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110528 is the FDA 510(k) clearance record for INTEGRA LED SURGICAL HEADLIGHT SYSTEM, a class II device, cleared for Integra LifeSciences Corporation on under FDA product code FSR (Light, Headband, Surgical). FDA records list 94 510(k) clearances for Integra LifeSciences Corporation, from to . As of , FDA records show no recalls naming K110528.

Clearance record

Decision date
Received
(76 days to decision)
Product code
FSR Light, Headband, Surgical
Regulation
21 CFR 886.4335
Device class
Class II
Review panel
Ophthalmic
Applicant
Integra LifeSciences Corporation 589 Davies Dr., York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FSR

Trailing 12 months

FDA records hold no clearances under product code FSR in the trailing twelve months.

FDA records show no clearances under product code FSR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FSR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260