The following data is part of a premarket notification filed by Bio-med U.s.a., Inc. with the FDA for Mx-7000 Microxel.
| Device ID | K111831 |
| 510k Number | K111831 |
| Device Name: | MX-7000 MICROXEL |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | BIO-MED U.S.A., INC. 111 ELLISON ST. Paterson, NJ 07505 |
| Contact | Young Chi |
| Correspondent | Young Chi BIO-MED U.S.A., INC. 111 ELLISON ST. Paterson, NJ 07505 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-28 |
| Decision Date | 2011-12-19 |
| Summary: | summary |