The following data is part of a premarket notification filed by Ilooda Co., Ltd. with the FDA for Secret Rf Smartcure Applicator With Electrodes.
| Device ID | K182355 |
| 510k Number | K182355 |
| Device Name: | Secret RF Smartcure Applicator With Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ilooda Co., Ltd. 120, Jangan-ro 458 Beon-gil, Jangan-Gu Suwon-si, KR |
| Contact | Yun-jung Ha |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | GEI |
| Subsequent Product Code | KCW |
| Subsequent Product Code | ONQ |
| Subsequent Product Code | OUH |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-30 |
| Decision Date | 2019-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023201376 | K182355 | 000 |
| 08800016903317 | K182355 | 000 |