Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K230663
Density · Jeisys Medical, Inc. · decided 2023-08-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Density B-Tip | Density B-Tip | Jeisys Medical Inc. | GEI | 08800020104250 |
| DENZA I-Tip II | DENZA I-Tip II | Jeisys Medical Inc. | GEI | 08800020103956 |
| Density Main body | Density Main body | Jeisys Medical Inc. | GEI | 08800020104304 |
| Density B-Tip II | Density B-Tip II | Jeisys Medical Inc. | GEI | 08800020104243 |
| Density I-Tip II | Density I-Tip II | Jeisys Medical Inc. | GEI | 08800020104236 |
| Density Handpiece | Density Handpiece | Jeisys Medical Inc. | GEI | 08800020104298 |
| DENZA F-Tip | DENZA F-Tip | Jeisys Medical Inc. | GEI | 08800020103949 |
| DENZA Handpiece | DENZA Handpiece | Jeisys Medical Inc. | GEI | 08800020103970 |
| DENZA TIP SET | DENZA TIP SET | Jeisys Medical Inc. | GEI | 08800020103987 |
| Density I-Tip | Density I-Tip | Jeisys Medical Inc. | GEI | 08800020104229 |
| DENZA B-Tip | DENZA B-Tip | Jeisys Medical Inc. | GEI | 08800020103925 |
| DENZA B-Tip II | DENZA B-Tip II | Jeisys Medical Inc. | GEI | 08800020103918 |
| Density F-Tip II | Density F-Tip II | Jeisys Medical Inc. | GEI | 08800020104274 |
| DENZA F-Tip II | DENZA F-Tip II | Jeisys Medical Inc. | GEI | 08800020103932 |
| Density TIP SET | Density TIP SET | Jeisys Medical Inc. | GEI | 08800020104281 |
| Density F-Tip | Density F-Tip | Jeisys Medical Inc. | GEI | 08800020104267 |
| DENZA I-Tip | DENZA I-Tip | Jeisys Medical Inc. | GEI | 08800020103963 |
| DENZA Main body | DENZA Main body | Jeisys Medical Inc. | GEI | 08800020103536 |
| DENSITY Handpiece | DT-HP-01 | Jeisys Medical Inc. | GEI | 08800020107626 |