The following data is part of a premarket notification filed by Ilooda Co., Ltd. with the FDA for Curas Nd:yag Laser.
| Device ID | K173038 |
| 510k Number | K173038 |
| Device Name: | CuRAS Nd:YAG Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ilooda Co., Ltd. 120, Jangan-ro 458 Beon-gil Jangan-Gu Suwon-si Gyeonggido, KR 16200 |
| Contact | Yun-jung Ha |
| Correspondent | Kathy Maynor Ronyam Enterprises LLC 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023200713 | K173038 | 000 |
| 08800023200256 | K173038 | 000 |
| 08800023200263 | K173038 | 000 |
| 08800023200270 | K173038 | 000 |
| 08800023200287 | K173038 | 000 |
| 08800023200294 | K173038 | 000 |
| 08800023200669 | K173038 | 000 |
| 08800023200676 | K173038 | 000 |
| 08800023200683 | K173038 | 000 |
| 08800023200690 | K173038 | 000 |
| 08800023200706 | K173038 | 000 |
| 08800023200249 | K173038 | 000 |