Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K231287
POTENZA · Jeisys Medical, Inc. · decided 2024-11-05 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| POTENZA Tip | Diamond Tip | Jeisys Medical Inc. | GEI | 08800020107282 |
| POTENZA Tip | C21-2 Tip | Jeisys Medical Inc. | GEI | 08800020101167 |
| POTENZA Tip | P1-08 | Jeisys Medical Inc. | GEI | 08800020101204 |
| POTENZA Tip | C21-1 Tip | Jeisys Medical Inc. | GEI | 08800020101150 |
| POTENZA | Foot Switch | Jeisys Medical Inc. | GEI | 08800020108395 |
| POTENZA Tip | C9 Tip | Jeisys Medical Inc. | GEI | 08800020101174 |
| POTENZA Tip | A1-15 | Jeisys Medical Inc. | GEI | 08800020101143 |
| POTENZA Tip | DDR Tip | Jeisys Medical Inc. | GEI | 08800020106292 |
| POTENZA Tip | S-25 Tip | Jeisys Medical Inc. | GEI | 08800020100269 |
| POTENZA Tip | S-49 Tip | Jeisys Medical Inc. | GEI | 08800020100245 |
| POTENZA Tip | S-16 Tip | Jeisys Medical Inc. | GEI | 08800020101198 |
| POTENZA Tip | I-25 Tip | Jeisys Medical Inc. | GEI | 08800020100252 |
| POTENZA Tip | A1-12 | Jeisys Medical Inc. | GEI | 08800020101136 |
| POTENZA Tip | I-49 Tip | Jeisys Medical Inc. | GEI | 08800020100238 |
| POTENZA Tip | I-16 Tip | Jeisys Medical Inc. | GEI | 08800020101181 |
| POTENZA Tip | SFA Tip | Jeisys Medical Inc. | GEI | 08800020106308 |
| POTENZA | POTENZA | Jeisys Medical Inc. | GEI | 08800020111012 |
| POTENZA Handpiece | AC Handpiece | Jeisys Medical Inc. | GEI | 08800020101754 |
| POTENZA Tip | CP-21 TIP | Jeisys Medical Inc. | GEI | 08800020100481 |
| POTENZA Handpiece | Motor Handpiece | Jeisys Medical Inc. | GEI | 08800020101778 |
| POTENZA Handpiece | S Handpiece | Jeisys Medical Inc. | GEI | 08800020101761 |