Omm Imports Inc.

Omm Imports Inc.

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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

Light Based Over The Counter Wrinkle Reduction (OHS) (5) Massager, Therapeutic, Electric (ISA) (2) Over-The-Counter Powered Light Based Laser For Acne (OLP) (2) Laser, Comb, Hair (OAP) (1)

Premarket Exempt

No Yes

Clear

Perfectio - 00850001456005 Catalog Number :

Device Description : Over the counter red and infrared phototherapy device for the treatment of wrinkles.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Perfectio + - 00850001456012 Catalog Number :

Device Description : Over the counter red and infrared phototherapy device for the treatment of wrinkles.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Sapphire - 00850001456029 Catalog Number :

Device Description : Over the counter blue LED phototherapy device for the treatment of acne.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

Perfectio X - 00850001456036 Catalog Number :

Device Description : Over the counter red/IR device for the treatment of wrinkles.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Recreo - 00850001456067 Catalog Number :

Device Description : Over the counter laser/led device for hair growth.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OAP

Prescription Use : No

Device Count : 1

Juvenis - 00850001456111 Catalog Number :

Device Description : Over the counter red/IR led device for the treatment of wrinkles.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Juvenis - 00850001456128 Catalog Number :

Device Description : Over the counter red/ir device for the treatment of wrinkles.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Sapphire X - 00850001456203 Catalog Number :

Device Description : Over the Counter Blue LED device for the treatment of acne.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

AECOR100 - Eye - 00850001456210 Catalog Number :

Device Class : 1

Duns Number: 010000704

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

AECOR200 - Neck - 00850001456227 Catalog Number :

Device Class : 1

Duns Number: 010000704

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

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