PIOON
GUDID 06974624060129
1470nm Medical Diode Laser
Wuhan Pioon Technology Co., Ltd.
General/multiple surgical diode laser system| Primary Device ID | 06974624060129 |
| NIH Device Record Key | 3a6eaabc-90da-4ae7-b883-3b1d6b052437 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIOON |
| Version Model Number | S1Pro |
| Company DUNS | 553185386 |
| Company Name | Wuhan Pioon Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974624060129 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231548
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
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 | 2024-01-31 |
| Device Publish Date | 2024-01-23 |
Devices Manufactured by Wuhan Pioon Technology Co., Ltd.
| 06974624060112 - I-LASER | 2024-07-08 1940nm Medical Diode Laser |
| 06974624060129 - PIOON | 2024-01-311470nm Medical Diode Laser |
| 06974624060129 - PIOON | 2024-01-31 1470nm Medical Diode Laser |
Trademark Results [PIOON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIOON 79275398 not registered Live/Pending |
WUHAN PIOON TECHNOLOGY CO., LTD. 2019-10-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.