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

Lamp, Infrared, Therapeutic Heating (ILY) (5) Light Based Over The Counter Wrinkle Reduction (OHS) (5) Over-The-Counter Powered Light Based Laser For Acne (OLP) (2)

Premarket Exempt

No Yes

Clear

BOOST LED DECOLLETAGE BIB - 05060534510388 Catalog Number : 112A

Device Description : Décolletage & Neck Device- Boost Branded (The Light Salon)- Black Controller

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Deesse Pro Express - 05060534510395 Catalog Number : 111B

Device Description : V2 facemask- Deesse Pro Express Branded (Harpar Grace)

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

MZ Skin LightMAX Supercharged LED Mask 2.0 - 05060534510418 Catalog Number : 140-MZ

Device Description : MZ Skin Mask: MZ Skin LightMAX Supercharged LED Mask 2.0

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OLP, OHS

Prescription Use : No

Device Count : 1

Boost LED Collar - 05060534510494 Catalog Number : 150-LS

Device Description : Boost LED Collar- The Light Salon

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Priori UnveiLED - 05060534510500 Catalog Number : 111A

Device Description : Priori UnveiLED (Lilac Colour)

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Shani Darden LED Light Therapy Mask - 05060534510517 Catalog Number : 115-HGSD

Device Description : Shani Darden Branded FacemaskBlue, Red & NIR facemask

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OLP, OHS

Prescription Use : No

Device Count : 1

Omnilux Men's - 05060534510524 Catalog Number :

Device Description : Omnilux Men's Facemask Device (Red & NIR).

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS, ILY

Prescription Use : No

Device Count : 1

UnveiLED Neck & Decollete - 05060534510586 Catalog Number : 112A

Device Description : Priori UnveiLED Neck & Decollete

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

UnveiLED Glove - 05060534510593 Catalog Number : 125A

Device Description : Priori UnveiLED Glove

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

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