Fraxis
Powered Laser Surgical Instrument
Ilooda Co. LTD
The following data is part of a premarket notification filed by Ilooda Co. Ltd with the FDA for Fraxis.
Pre-market Notification Details
| Device ID | K172096 |
| 510k Number | K172096 |
| Device Name: | Fraxis |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ilooda Co. LTD 120, Jangan-Ro 458 Beon-Gil Jangan-Gu Suwon-si Gyeonggido, KR 16200 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor Emvera Technologies, LLC 641 10th St Cedartown, GA 30125 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-11 |
| Decision Date | 2017-08-09 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023200904 | K172096 | 000 |
| 08800023200881 | K172096 | 000 |
| 08800023200898 | K172096 | 000 |
| 08800016903980 | K172096 | 000 |
| 08800016903973 | K172096 | 000 |
| 08800016903966 | K172096 | 000 |
| 08800016903959 | K172096 | 000 |
Trademark Results [Fraxis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FRAXIS 90186612 not registered Live/Pending |
ILOODA Co., Ltd. 2020-09-16 |
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