The following data is part of a premarket notification filed by Diotech Co with the FDA for Atoven-reusable Laser Fiber.
| Device ID | K152667 |
| 510k Number | K152667 |
| Device Name: | ATOVEN-Reusable Laser Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOTECH CO 301, NAKDONG-DAERO, SAHA-GU Busan, KR 604812 |
| Contact | Lee Kyung Yong |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD STREET Pittsburgh, PA 15213 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-17 |
| Decision Date | 2016-06-09 |
| Summary: | summary |