The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for D-laser Blue, D-laser 16.
| Device ID | K210367 |
| 510k Number | K210367 |
| Device Name: | D-Laser Blue, D-Laser 16 |
| Classification | Laser, Dental, Soft Tissue |
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin, CN 541004 |
| Contact | Yang Yunfeng |
| Correspondent | Fu Ailing Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, CN 518055 |
| Product Code | NVK |
| Subsequent Product Code | GEX |
| Subsequent Product Code | ILY |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2022-03-10 |