POLY Go
GUDID B3437000CA1
Hand Held LED Light Therapy Device. Uses LED to treat mild to moderate Acne. Contains rechargeable Battery
Medtek Lighting Corporation
Blue/red/infrared phototherapy lamp| Primary Device ID | B3437000CA1 |
| NIH Device Record Key | 7f0074f6-72c6-4b36-9a2b-489780dc5db0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POLY Go |
| Version Model Number | POLY Go Clear |
| Company DUNS | 002692106 |
| Company Name | Medtek Lighting Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 Dimensions
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
| Area/Surface Area | 25 Square centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B3437000CA1 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180900
FDA Product Code
| OLP | Over-The-Counter Powered Light Based Laser For Acne |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
On-Brand Devices [POLY Go]
| 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 |
Trademark Results [POLY Go]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLY GO 88383794 5885085 Live/Registered |
U V BIOTEK, LLC 2019-04-12 |
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