The following data is part of a premarket notification filed by Ilooda Co., Ltd. with the FDA for Reticapture.
| Device ID | K173474 |
| 510k Number | K173474 |
| Device Name: | RetiCapture |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Ilooda Co., Ltd. 120, Jangan-ro 458beon-gil, Jangan-gu Suwon-si, KR 16200 |
| Contact | Yun-jung Ha |
| Correspondent | Mina Joo BT Solutions, Inc. Unit 502, 148 Yeoksam-ro Seoul, KR 06249 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-09 |
| Decision Date | 2018-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023201017 | K173474 | 000 |
| 08800016904055 | K173474 | 000 |