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 |