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) (7) Light Based Over The Counter Wrinkle Reduction (OHS) (2) Over-The-Counter Powered Light Based Laser For Acne (OLP) (1)

Premarket Exempt

No Yes

Clear

Currentbody Skin Neck & Dec Perfector - 05060534510142 Catalog Number : 112A

Device Description : Décolletage & Neck Device- Currentbody Skin Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

UnveiLED (Priori) - 05060534510159 Catalog Number : 111A

Device Description : V1 facemask- Priori/ UnveiLED (Blue)

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

faceLITE USA - 05060534510166 Catalog Number : 111B

Device Description : V2 facemask- faceLITE USA Branded (Refine USA)

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

NECOLLAGE (Opatra) - 05060534510203 Catalog Number : 112A

Device Description : LED Décolletage & Neck Device-Opatra Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Omnilux Contour GLOVE - 05060534510210 Catalog Number : 125A

Device Description : LED Glove Device- Omnilux Contour Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Dp Dermaceuticals L.E.D. HAND - 05060534510227 Catalog Number : 125A

Device Description : LED Glove Device- DP Dermaceuticals Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Omnilux CLEAR - 05060534510234 Catalog Number : 135-OC

Device Description : Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

handLITE - 05060534510241 Catalog Number : 125A

Device Description : LED glove device- handLITE branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

Current Body Skin Hand Perfector - 05060534510340 Catalog Number :

Device Description : Glove Device- Currentbody Branded

Device Class : 2

Duns Number: 223616320

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

BOOST LED BODY PATCH - 05060534510364 Catalog Number : 145A

Device Description : LED Body Panel- 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

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