Unit, Cryophthalmic, Ac-powered

Device Code: 4322

Product Code(s): HRN

Device Classification Information

Device Type ID4322
Device NameUnit, Cryophthalmic, Ac-powered
Regulation DescriptionCryophthalmic Unit.
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)
CFR Regulation Number886.4170 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHRN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID4322
DeviceUnit, Cryophthalmic, Ac-powered
Product CodeHRN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCryophthalmic Unit.
CFR Regulation Number886.4170 [🔎]
Premarket Reviews
ManufacturerDecision
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
 
SUBSTANTIALLY EQUIVALENT
1
PHAKOS
 
SUBSTANTIALLY EQUIVALENT
2
Device Problems
Difficult To Remove
1
Device Operates Differently Than Expected
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:46:56

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