The following data is part of a premarket notification filed by Daeju Meditech Engineering Co., Ltd. with the FDA for Aroma Grand.
| Device ID | K211637 |
| 510k Number | K211637 |
| Device Name: | AROMA GRAND |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Daeju Meditech Engineering Co., Ltd. #501-504, HausD Sejong Tower, 26, Seongsu-il-ro L0gil, Seongdong-gu Seoul, KR 04793 |
| Contact | Seongun Kim |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-27 |
| Decision Date | 2021-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800017500126 | K211637 | 000 |