The following data is part of a premarket notification filed by Elemenic Co., Ltd. with the FDA for Element-tl.
| Device ID | K180224 |
| 510k Number | K180224 |
| Device Name: | ELEMENT-TL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Elemenic Co., Ltd. 3rd, 34 , Gyeongin-ro 3beon-gil Bucheon-si, KR 14731 |
| Contact | Jo Won Ju |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt 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 | 2018-01-26 |
| Decision Date | 2018-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800088900009 | K180224 | 000 |