The following data is part of a premarket notification filed by Ilooda Co Ltd with the FDA for Secret Duo.
| Device ID | K213250 |
| 510k Number | K213250 |
| Device Name: | Secret Duo |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ilooda Co Ltd 120, Jangan-Ro 458 Beon-Gil Jangan-Gu Suwon-Si, KR 16200 |
| Contact | Moon Mason |
| Correspondent | Kathy Maynor Kathy Maynor Consulting 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 | 2021-09-30 |
| Decision Date | 2022-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023200966 | K213250 | 000 |
| 08800023201390 | K213250 | 000 |
| 08800023201239 | K213250 | 000 |
| 08800023200959 | K213250 | 000 |
| 08800023200942 | K213250 | 000 |
| 08800016904659 | K213250 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SECRET DUO 98236783 not registered Live/Pending |
ILOODA Co., Ltd. 2023-10-23 |