Primary Device ID | B58613752 |
NIH Device Record Key | f85e3cfd-d46b-4af2-8c9d-e8f00f8c30f0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Skin Renu Laser |
Version Model Number | SRL |
Catalog Number | 13752 |
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 | B58613752 [Primary] |
ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output |
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 | 2020-07-21Skin Renu Laser |
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 | 2020-07-21 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 |