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FSR — Light, Headband, Surgical Class II

FDA Device Classification

Classification Details

Product Code
FSR
Device Class
Class II
Regulation Number
886.4335
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K110528integra lifesciences corporationINTEGRA LED SURGICAL HEADLIGHT SYSTEMMay 11, 2011
K031549welch allynSOLID STATE LAMP [LED] HEADLIGHTAugust 11, 2003
K031548welch allynLED HEADLIGHTAugust 11, 2003
K994362angiolazHEADLAMP HL2000.May 11, 2000