The following data is part of a premarket notification filed by Ilooda Co., Ltd. with the FDA for Reepot Nd; Yag Laser System.
| Device ID | K222555 |
| 510k Number | K222555 |
| Device Name: | Reepot Nd; YAG Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ilooda Co., Ltd. 9F, 25, Deokcheon-Ro 152beon-Gil, Manan-Gu Anyang-Si, KR 14084 |
| Contact | Yunjung HA |
| Correspondent | Do Hyun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-ru Seoul, KR 06210 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-23 |
| Decision Date | 2022-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023202182 | K222555 | 000 |
| 08800023202175 | K222555 | 000 |
| 08800023202168 | K222555 | 000 |