Primary Device ID | 00850062978003 |
NIH Device Record Key | 95d34491-fd3f-48cc-acb3-884edd946f11 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WORLD AESTHETIX BROAD PULSED LIGHT |
Version Model Number | WAX161286 |
Company DUNS | 931002047 |
Company Name | WORLD AESTHETIX LLC |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850062978003 [Primary] |
ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-03 |
Device Publish Date | 2024-06-25 |
00850062978010 - NuSkin RF Micro | 2024-12-23 The NuSkin RF Micro is intended for use in dermatologic and general surgical procedures for electrocoagulation |
00850062978003 - WORLD AESTHETIX BROAD PULSED LIGHT | 2024-07-03The World Aesthetix Broad Pulsed Light device is indicated for use in surgical, aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. |
00850062978003 - WORLD AESTHETIX BROAD PULSED LIGHT | 2024-07-03 The World Aesthetix Broad Pulsed Light device is indicated for use in surgical, aesthetic applications in permanent hair reducti |