FDA.reportPublic FDA data

Poly Spot

Primary DI
B3437000C21
Brand
Poly Spot
Company
Medtek Lighting Corporation
Model
7000C2
Device description
Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633nm), help to mitigate a variety of skin conditions.There are 8 LEDs to provide a treatment area of 4 sq. cm. Batery powered with a charger
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
OTC
true

Product Codes#

Code, Name table
CodeName
PWCGeneral Wellness Product

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWCGeneral Wellness ProductUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3437000C21PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable mains electricity (AC-powered) device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). It is normally available [non-prescription] over-the-counter (OTC) for use by the patient in the home or by a healthcare professional in a clinical setting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area4Square centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002692106
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B343ML600UVBioTekMobile LiteML6002017-02-09
B3437000A1POLY7000A2017-08-31
B3437000A2Poly ProPoly Pro Rejuv2018-09-19
B3437000A3POLY ProRegen2018-10-31
B3437000C1Poly Go7000C2017-09-01
B3437000CA1POLY GoPOLY Go Clear2018-09-17
B343B100UVBioTek100B100B2017-02-09
B343B1600UVBioTek1600B1600B2017-02-09
B343B20UVBioTek20B20B2017-02-09
B343B2400UVBioTek2400B2400B2017-02-09
B343B3200UVBioTek3200B3200B2017-02-09
B343B40UVBioTek40B40B2017-02-09
B343B4000UVBioTek4000B4000B2017-02-09
B343B60UVBioTerk60B60B2017-02-09
B343B80UVBioTek80B80B2017-02-09
B343B800UVBioTek800B800B2017-02-09
B343MD3UVBioTekMulti DirectionalMD32017-02-09
B343VL1400UVBioTekVersa-Lite 1400VL14002017-02-09
B343CT2000Peacock Tanning2000CT2000CT2017-02-09
B343CT3200Peacock Tanning3200CT3200CT2017-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978959250040Bed Wedge Pillow (7 inch)Xiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
06978959250057Big Wedge PillowXiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
06978959250118Leg Elevation Pillow (CoolingGel)Xiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
15060498452189Motion Medical DistributingHaslam Medical, Inc.PWC2022-12-29
00815948024229REAL Immersive SystemPENUMBRA, INC.PWC2021-09-14
B3437000A3POLY ProMedtek Lighting CorporationPWC2018-10-31
B3437000C1Poly GoMedtek Lighting CorporationPWC2017-09-01