PSORIA-SHIELD 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, Ultraviolet, Dermatological (FTC) (1)

Premarket Exempt

Clear

Aurora - B780AUR20000 Catalog Number :

Device Description : The Aurora is indicated for use in targeted PUVA photochemistry and UVB photothe The Aurora is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

Device Class : 2

Duns Number: 962442633

Premarket Exempt : No

Product Code : FTC

Prescription Use : Yes

Device Count : 1

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