The following data is part of a premarket notification filed by Union Medical Engeneering Co., Ltd. with the FDA for Um-l25.
| Device ID | K000222 |
| 510k Number | K000222 |
| Device Name: | UM-L25 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | UNION MEDICAL ENGENEERING CO., LTD. 1200 N.W. 78TH ST. SUITE 110 Miami, FL 33126 |
| Contact | Annie Velez |
| Correspondent | Annie Velez UNION MEDICAL ENGENEERING CO., LTD. 1200 N.W. 78TH ST. SUITE 110 Miami, FL 33126 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-04-19 |