POLY

GUDID B3437000A1

LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are available individually on treatment heads or a mix of wavelengths on the same treatment head. There is a Touch Screen Display for entering treatment times and selecting treatment heads. The unit is mounted on a base with casters for moving around a clinic.

Medtek Lighting Corporation

Blue/red/infrared phototherapy lamp
Primary Device IDB3437000A1
NIH Device Record Key7719b4d5-eb9d-4f81-99ec-03b2f859e073
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOLY
Version Model Number7000A
Company DUNS002692106
Company NameMedtek Lighting Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Dimensions

Weight60 Pound
Weight60 Pound
Weight60 Pound
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound
Area/Surface Area800 Square centimeter
Weight60 Pound

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3437000A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-09
Device Publish Date2017-08-31

Devices Manufactured by Medtek Lighting Corporation

B3437000A1 - POLY2020-03-09LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are available individually on treatment heads or a mix of wavelengths on the same treatment head. There is a Touch Screen Display for entering treatment times and selecting treatment heads. The unit is mounted on a base with casters for moving around a clinic.
B3437000A1 - POLY2020-03-09 LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are ava
B343B100 - UVBioTek2018-12-21 Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to wall or to stand.
B343B1600 - UVBioTek2018-12-21 Phototherapy Unit. UVB Narrowband. 4 Connected Panels, attached to a wall, wrap around patient. 16 lamps, each 72" in height.
B343B20 - UVBioTek2018-12-21 Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72" Lamps. Mounts to Wall.
B343B2400 - UVBioTek2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 24 lamps, each 72" in height. Cl
B343B3200 - UVBioTek2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 32 Lamps, each 72" in height. Cl
B343B40 - UVBioTek2018-12-21 Phototherapy Unit. UVB Narrowband. Single upright panel with Four 72" lamps. Mounts to wall or stand.
B343B4000 - UVBioTek2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 40 lamps, each 72" in height. Cl

Trademark Results [POLY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLY
POLY
98202787 not registered Live/Pending
Plantronics, Inc.
2023-09-28
POLY
POLY
98202750 not registered Live/Pending
Plantronics, Inc.
2023-09-28
POLY
POLY
98129333 not registered Live/Pending
Poly Inc
2023-08-11
POLY
POLY
97695965 not registered Live/Pending
SEW-EURODRIVE GmbH & Co KG
2022-11-29
POLY
POLY
97611794 not registered Live/Pending
Alpha Coffee, Inc.
2022-09-28
POLY
POLY
90900474 not registered Live/Pending
POLY US, L.L.C.
2021-08-24
POLY
POLY
90883146 not registered Live/Pending
Pal Labs Inc.
2021-08-14
POLY
POLY
88898516 not registered Live/Pending
Kamel Greene
2020-05-03
POLY
POLY
88705904 not registered Live/Pending
Google LLC
2019-11-25
POLY
POLY
88343347 not registered Live/Pending
Plantronics, Inc.
2019-03-17
POLY
POLY
88343345 not registered Live/Pending
Plantronics, Inc.
2019-03-17
POLY
POLY
88343344 not registered Live/Pending
Plantronics, Inc.
2019-03-17

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