Medtek Lighting Corporation

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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, Ultraviolet, Dermatological (FTC) (4) General Wellness Product (PWC) (3) Light Based Over The Counter Wrinkle Reduction (OHS) (1) Over-The-Counter Powered Light Based Laser For Acne (OLP) (1) Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

No Yes

Clear

POLY - B3437000A1 Catalog Number :

Device Description : LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm)

Device Class : 2

Duns Number: 002692106

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Poly Pro - B3437000A2 Catalog Number :

Device Description : LED Light Therapy Device. Uses 1820 LEDs at 633nm to treat facial wrinkles. Avai

Device Class : 2

Duns Number: 002692106

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

POLY Pro - B3437000A3 Catalog Number :

Device Description : LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pa

Device Class : U

Duns Number: 002692106

Premarket Exempt : Yes

Product Code : PWC

Prescription Use : No

Device Count : 1

Poly Go - B3437000C1 Catalog Number :

Device Description : Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Bl

Device Class : U

Duns Number: 002692106

Premarket Exempt : Yes

Product Code : PWC

Prescription Use : No

Device Count : 1

Poly Spot - B3437000C21 Catalog Number :

Device Description : Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or

Device Class : U

Duns Number: 002692106

Premarket Exempt : Yes

Product Code : PWC

Prescription Use : No

Device Count : 1

POLY Go - B3437000CA1 Catalog Number :

Device Description : Hand Held LED Light Therapy Device. Uses LED to treat mild to moderate Acne. Con

Device Class : 2

Duns Number: 002692106

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

UVBioTek - B343B100 Catalog Number : 100B

Device Description : Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to

Device Class : 2

Duns Number: 002692106

Premarket Exempt : No

Product Code : FTC

Prescription Use : Yes

Device Count : 1

UVBioTek - B343B1600 Catalog Number : 1600B

Device Description : Phototherapy Unit. UVB Narrowband. 4 Connected Panels, attached to a wall, wrap

Device Class : 2

Duns Number: 002692106

Premarket Exempt : No

Product Code : FTC

Prescription Use : Yes

Device Count : 1

UVBioTek - B343B20 Catalog Number : 20B

Device Description : Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72" Lamps. Mou

Device Class : 2

Duns Number: 002692106

Premarket Exempt : No

Product Code : FTC

Prescription Use : Yes

Device Count : 1

UVBioTek - B343B2400 Catalog Number : 2400B

Device Description : Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap

Device Class : 2

Duns Number: 002692106

Premarket Exempt : No

Product Code : FTC

Prescription Use : Yes

Device Count : 1

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