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 |