PULSADERM 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

Over-The-Counter Powered Light Based Laser For Acne (OLP) (5) Laser, Comb, Hair (OAP) (2) Light Based Over The Counter Wrinkle Reduction (OHS) (2) Stimulator, Transcutaneous Electrical, Aesthetic Purposes (NFO) (1)

Premarket Exempt

Clear

Instant Face Lift - 00858830007023 Catalog Number :

Device Description : Handheld device intended for facial stimulation

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : NFO

Prescription Use : No

Device Count : 1

LED Blue Acne Clearing Mask - 00858830007047 Catalog Number :

Device Description : Blue LED Light for the treatment of acne

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

Orbital LED Mask - 00858830007061 Catalog Number :

Device Description : LED light for the treatment of wrinkles

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Hair Laser Helmet - 00858830007191 Catalog Number :

Device Description : Laser Device for promotion of hair growth.

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OAP

Prescription Use : No

Device Count : 1

Pulsaderm - 00858830007764 Catalog Number :

Device Description : Blue LED Light for the treatment of acne

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

A.C.E Blue - 00864918000305 Catalog Number :

Device Description : Blue Light for the treatment of acne

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

Pulsaderm RED LED Skin Renewal - 00864918000312 Catalog Number :

Device Description : Red LED Light for Wrinkles

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Blue LED Acne Clearing Light - 00864918000329 Catalog Number :

Device Description : Blue LED Light for the treatment of mild to moderate acne

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

A.C.E Red and Blue - 00864918000336 Catalog Number :

Device Description : LED light for the treatment of acne

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

NutraStim Hair Laser Comb - 00864918000343 Catalog Number :

Device Description : Hair Growth Laser Light Device

Device Class : 2

Duns Number: 080429881

Premarket Exempt : No

Product Code : OAP

Prescription Use : No

Device Count : 1

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