The following data is part of a premarket notification filed by Ilooda Co Ltd with the FDA for Secret Duo.
| Device ID | K202043 |
| 510k Number | K202043 |
| Device Name: | Secret Duo |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ilooda Co Ltd 120, Jangan-Ro 458 Beon-Gil Jangan-Gu Suwon-si Gyeonggido, KR 16200 |
| Contact | Kevin Walls |
| 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 | 2020-07-23 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800016904666 | K202043 | 000 |
| 08800016904642 | K202043 | 000 |
| 08800016904635 | K202043 | 000 |
| 08800016904628 | K202043 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SECRET DUO 98236783 not registered Live/Pending |
ILOODA Co., Ltd. 2023-10-23 |