Shenzhen Slinph Technology Co., Ltd.

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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

Laser, Comb, Hair (OAP) (1)

Premarket Exempt

Clear

iHelmet - 06971008070019 Catalog Number :

Device Description : iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila - V and for both, Fitzpatrick Classification of Skin Phototypes of l - IV.

Device Class : 2

Duns Number: 544372553

Premarket Exempt : No

Product Code : OAP

Prescription Use : No

Device Count : 1

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