The following data is part of a premarket notification filed by Ilooda Co., Ltd with the FDA for Vikini Diode Laser System.
| Device ID | K151232 |
| 510k Number | K151232 |
| Device Name: | VIKINI Diode Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ILOODA CO., LTD #801-805, Venture Valley 40, Omokcheon-ro 152 Beon-gil Gwonseon-gu, Suwon-si, KP |
| Contact | Suhee Nam |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-08 |
| Decision Date | 2015-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023200225 | K151232 | 000 |
| 08800023200218 | K151232 | 000 |