Remax Medi-Tech (Shenzhen) Corporation

Address:Room 303 of Factory Building, No. 32, Huiming Yi Road,Shenzhen Guangdong,CN

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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

Laser, Comb, Hair (OAP) (2)

Premarket Exempt

Clear

iRestore - 00859690003361 Catalog Number :

Device Description : The iRestore Hair Growth System is indicated to promote hair growth in females w The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Device Class :

Duns Number: 544382003

Premarket Exempt : No

Product Code : OAP

Prescription Use : No

Device Count : 1

iRestore - 00859690003897 Catalog Number :

Device Description : iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have NorwoodHamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II . All users should also have Fitzpatrick Skin Types I to IV.