DIAGNOSYS LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Corneal (HLZ) (2)

Premarket Exempt

Clear

Gold Lens - 00855730007320 Catalog Number : D101

Device Description : Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : HLZ

Prescription Use : No

Device Count : 1

Gold Lens - 00855730007337 Catalog Number : D102

Device Description : Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).