The following data is part of a premarket notification filed by Bio-med Usa Inc with the FDA for Picore.
| Device ID | K212082 |
| 510k Number | K212082 |
| Device Name: | Picore |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Bio-Med USA Inc 27 New England Dr Ramsey, NJ 07446 |
| Contact | Young Chi |
| Correspondent | Young Chi Bio-Med USA Inc 27 New England Dr Ramsey, NJ 07446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2021-10-06 |