The following data is part of a premarket notification filed by Ilooda Co., Ltd with the FDA for Fraxis Duo.
| Device ID | K160312 |
| 510k Number | K160312 |
| Device Name: | FRAXIS DUO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ILOODA CO., LTD 120, JANGAN-RO 458 BEON-GIL JANGAN-GU Suwon-si, KR 100-85816200 |
| Contact | Yun Jung Ha |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | GEX |
| Subsequent Product Code | GEI |
| Subsequent Product Code | OUH |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-05 |
| Decision Date | 2016-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023200041 | K160312 | 000 |
| 08800023200027 | K160312 | 000 |
| 08800023200010 | K160312 | 000 |
| 08800016903669 | K160312 | 000 |
| 08800016903652 | K160312 | 000 |
| 08800016903645 | K160312 | 000 |
| 08800016903638 | K160312 | 000 |
| 08800016903621 | K160312 | 000 |
| 08800016903195 | K160312 | 000 |