EARLENS CORPORATION

Address:4045A Campbell Avenue,Menlo Park,CA,94025,US

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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

Tympanic Membrane Direct Contact Hearing Aid (PLK) (10)

Premarket Exempt

No Yes

Clear

Earlens Processor - 00850013007011 Catalog Number : PREL1XX

Device Description : Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 1

Earlens Charger - 00850013007035 Catalog Number : CHEL101

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 1

Earlens ELF USB - 00850013007042 Catalog Number : ELF001

Device Description : Earlens Fitting Software. Lot Number is for manufacturing packaging of software Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : No

Device Count : 1

Earlens Light Tip - 00850013007059 Catalog Number : LTEL1X

Device Description : Light Tip comes in L - Left, R - Right

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 1

Earlens Light Tip - 00850013007066 Catalog Number : LTEL1LR

Device Description : Light Tip w/ left & right packaged

Device Class :

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 2

Earlens Processor & Light Tip - 00850013007073 Catalog Number : PLEL1X

Device Description : Kit containing 1 Processor and 1 LIght Tip that are connected togetherProcessor Kit containing 1 Processor and 1 LIght Tip that are connected togetherProcessor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - BrownLT comes in L - Left, R - Right

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 1

Earlens Tympanic Lens - 00850013007097 Catalog Number : TLEL1X

Device Description : Tympanic Lens L- left, R - Right

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 1

Earlens Tympanic Lens - 00850013007103 Catalog Number : TLEL1LR

Device Description : Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.

Device Class :

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 2

Earlens Wireless Programmer - 00850013007110 Catalog Number : WPUSB01

Device Description : Software version is in Application Identifier (8012)Lot Number reflects software Software version is in Application Identifier (8012)Lot Number reflects software assembly/packaging lot number

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : No

Device Count : 1

Earlens Processor - 00850013007202 Catalog Number : IPR01XX

Device Description : Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black

Device Class : 2

Duns Number: 611658795

Premarket Exempt : No

Product Code : PLK

Prescription Use : Yes

Device Count : 1

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