| Primary Device ID | B5863386 |
| NIH Device Record Key | 7d09f36e-89a4-4244-ad16-91683189b3c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Positively Clear Acne Clearing Blue Light |
| Version Model Number | BL2 |
| Catalog Number | 3386 |
| Company DUNS | 080705345 |
| Company Name | Tria Beauty |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | B5863386 [Primary] |
| OLP | Over-The-Counter Powered Light Based Laser For Acne |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-21 |
| Device Publish Date | 2020-07-13 |
| B58613752 - Skin Renu Laser | 2020-07-21 Skin Renu Laser |
| B5863159 - HAIR REMOVAL LASER | 2020-07-21 Hair Removal Laser 4X, White with Green - Korea |
| B5863192 - HAIR REMOVAL LASER | 2020-07-21 Hair Removal Laser 4X, White with Fuchsia - Korea |
| B5863386 - Positively Clear Acne Clearing Blue Light | 2020-07-21Positively Clear Acne Clearing Blue Light - Korea |
| B5863386 - Positively Clear Acne Clearing Blue Light | 2020-07-21 Positively Clear Acne Clearing Blue Light - Korea |
| B5863634 - Hair Removal Laser Precisison | 2020-07-21 Hair Removal Laser Precision - White - Korea |
| B5863725 - HAIR REMOVAL LASER | 2020-07-21 Hair Removal Laser 4X, White with Grey |
| B5863724 - HAIR REMOVAL LASER | 2018-07-23 Hair Removal Laser 4X, White with Fuchsia |
| B5863374 - Positively Clear | 2018-07-16 |