The following data is part of a premarket notification filed by Smedtrum Medical Technology Co., Ltd. with the FDA for Co2 Laser System.
| Device ID | K221597 |
| 510k Number | K221597 |
| Device Name: | CO2 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, TW 248016 |
| Contact | Crimson Wu |
| Correspondent | Crimson Wu Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, TW 248016 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-02 |
| Decision Date | 2022-09-15 |