Clip, Lens, Trial, Ophthalmic

Device Code: 4270

Product Code(s): HPB

Device Classification Information

Device Type ID4270
Device NameClip, Lens, Trial, Ophthalmic
Regulation DescriptionOphthalmic Trial Lens Clip.
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 Number886.1410 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHPB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4270
DeviceClip, Lens, Trial, Ophthalmic
Product CodeHPB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Trial Lens Clip.
CFR Regulation Number886.1410 [🔎]
TPLC Last Update: 2019-04-02 20:45:51

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