Primary Device ID | B3437000C1 |
NIH Device Record Key | ccb3242b-c72d-4d9a-87ad-756e706c5897 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Poly Go |
Version Model Number | 7000C |
Company DUNS | 002692106 |
Company Name | Medtek Lighting Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B3437000C1 [Primary] |
PWC | General Wellness Product |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-09-01 |
B3437000CA1 | Hand Held LED Light Therapy Device. Uses LED to treat mild to moderate Acne. Contains rechargeab |
B3437000C1 | Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Blue (415nm) and I |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POLY GO 88383794 5885085 Live/Registered |
U V BIOTEK, LLC 2019-04-12 |