Duns Number:002692106
Device Description: LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Inf 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.
Catalog Number
-
Brand Name
POLY
Version/Model Number
7000A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170187
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
7719b4d5-eb9d-4f81-99ec-03b2f859e073
Public Version Date
July 07, 2020
Public Version Number
6
DI Record Publish Date
August 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |
| U | Unclassified | 3 |