Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K112154
FEMTO LDV · Sie Ag,Surgical Instument Engineering · decided 2012-03-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Procedure Pack | 9.5 CS | SIE AG, Surgical Instrument Engineering | HQF | 07640167750467 |
| Procedure Pack | 8.5 ACS | SIE AG, Surgical Instrument Engineering | HQF | 07640167750405 |
| Procedure Pack | 9.0 LASIK | SIE AG, Surgical Instrument Engineering | HQF | 07640167750498 |
| SIM-LASIK Pack | 8.5 | SIE AG, Surgical Instrument Engineering | HQF | 07640167750368 |
| FEMTO LDVᵀᴹ Intershields | d300 | SIE AG, Surgical Instrument Engineering | HQF | 07640167750801 |
| FEMTO LDV | Z4 | SIE AG, Surgical Instrument Engineering | HQF | 07640167750030 |
| Procedure Pack | 9.5 ACS | SIE AG, Surgical Instrument Engineering | HQF | 07640167750429 |
| Procedure Pack | 9.5/140 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750238 |
| Procedure Pack | 8.5/100 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750139 |
| Procedure Pack | 10.0 CS | SIE AG, Surgical Instrument Engineering | HQF | 07640167750436 |
| Procedure Pack | 8.5/140 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750153 |
| Procedure Pack | 9.5/90 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750245 |
| SIM-LASIK Pack | 9.0 | SIE AG, Surgical Instrument Engineering | HQF | 07640167750375 |
| Procedure Pack | 8.5/110 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750146 |
| Procedure Pack | 10.0 LASIK | SIE AG, Surgical Instrument Engineering | HQF | 07640167750474 |
| FEMTO LDVᵀᴹ Intershields | d330 | SIE AG, Surgical Instrument Engineering | HQF | 07640167750818 |
| Procedure Pack | 9.0 ACS | SIE AG, Surgical Instrument Engineering | HQF | 07640167750412 |
| Procedure Pack | 9.0/110 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750184 |
| Procedure Pack | 10/110 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750108 |
| FEMTO LDVᵀᴹ Intershields | d420 | SIE AG, Surgical Instrument Engineering | HQF | 07640167750849 |
| Procedure Pack | 10.0 ACS | SIE AG, Surgical Instrument Engineering | HQF | 07640167750399 |
| Procedure Pack | 8.5 CS | SIE AG, Surgical Instrument Engineering | HQF | 07640167750443 |
| Procedure Pack | 8.5 LASIK | SIE AG, Surgical Instrument Engineering | HQF | 07640167750481 |
| Procedure Pack | 8.5/90 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750160 |
| Procedure Pack | 10/140 | SIE AG, Surgical Instrument Engineering | GEX HNO HQF | 07640167750115 |