Probe, Lachrymal

Device Code: 4232

Product Code(s): HNL

Device Classification Information

Device Type ID4232
Device NameProbe, Lachrymal
Regulation DescriptionManual Ophthalmic Surgical Instrument.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.4350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHNL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4232
DeviceProbe, Lachrymal
Product CodeHNL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Ophthalmic Surgical Instrument.
CFR Regulation Number886.4350 [🔎]
Device Problems
Break
2
Total Device Problems 2
Recalls
Manufacturer Recall Class Date Posted
1
Quest Medical, Inc.
II Apr-02-2015
TPLC Last Update: 2019-04-02 20:45:12

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