The following data is part of a premarket notification filed by Bio-med Usa Inc. with the FDA for Cellene Co2 Laser System.
| Device ID | K182270 |
| 510k Number | K182270 |
| Device Name: | Cellene CO2 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Bio-Med USA Inc. 27 New England Drive Ramsey, NJ 07446 |
| Contact | Young Chi |
| Correspondent | Young Chi Bio-Med USA Inc. 27 New England Drive Ramsey, NJ 07446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-22 |
| Decision Date | 2018-11-02 |
| Summary: | summary |