The following data is part of a premarket notification filed by Bio-med Usa Inc with the FDA for Dental 5 Multi Diode Laser.
| Device ID | K163638 |
| 510k Number | K163638 |
| Device Name: | Dental 5 Multi Diode Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIO-MED USA INC 111 ELLISON STREET Paterson, NJ 07505 |
| Contact | Young Chi |
| Correspondent | Young Chi BIO-MED USA INC 111 ELLISON STREET Paterson, NJ 07505 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-05-15 |
| Summary: | summary |