I-SMART DEVELOPMENTS LIMITED

Address:129, Green lanes,Sutton Coldfield Birmingham,GB

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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) (7) Lamp, Infrared, Therapeutic Heating (ILY) (3)

Premarket Exempt

No Yes

Clear

Kandyway Eternal Glow MD - Face - 00628011719515 Catalog Number : 111B

Device Description : Kandyway Eternal Glow MD - Face (V2 Facemask)Legal Manufacturer- I-Smart Developments Ltd

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

faceLITE - 05060534510012 Catalog Number : 111A

Device Description : V1 facemask- faceLITE Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

decoLITE - 05060534510036 Catalog Number : 112A

Device Description : Décolletage & Neck Device- decoLITE Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Boost LED Face Mask - 05060534510043 Catalog Number : 111A

Device Description : V1 facemask- Boost Branded (The Light Salon)- Black Controller

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Currentbody Skin LED Light Therapy Mask - 05060534510081 Catalog Number : 111A

Device Description : V1 facemask- Currentbody Skin Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Skinlite - 05060534510098 Catalog Number : 111B

Device Description : V2 facemask- Skinlite Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Dp Dermaceuticals L.E.D. FACE - 05060534510104 Catalog Number : 111B

Device Description : v2 Facemask- DP Dermaceuticals Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Dp Dermaceuticals Neck & Décolleté - 05060534510111 Catalog Number : 112A

Device Description : LED Décolletage & Neck Device- DP Dermaceuticals Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Omnilux Contour FACE - 05060534510128 Catalog Number : 111B

Device Description : V2 facemask- Omnilux Contour FACE Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Omnilux Contour NECK & DECOLLETE - 05060534510135 Catalog Number : 112A

Device Description : LED Neck & Décolletage Device- Omnilux Contour Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

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