Fluid, Intraocular

Device Code: 4337

Product Code(s): LWL

Device Classification Information

Device Type ID4337
Device NameFluid, Intraocular
Regulation DescriptionIntraocular Fluid.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Contact Lenses And Retinal Devices Branch (CLRD)
Submission TypePMA
CFR Regulation Number886.4275 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeLWL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4337
DeviceFluid, Intraocular
Product CodeLWL
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionIntraocular Fluid.
CFR Regulation Number886.4275 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
4
Difficult To Remove
1
Total Device Problems 5
TPLC Last Update: 2019-04-02 20:47:13

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