The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Lumenis Pulse 120h.
| Device ID | K140388 |
| 510k Number | K140388 |
| Device Name: | LUMENIS PULSE 120H |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS LTD. 155 BIALIK STREET Ramat Gan, IL 5252346 |
| Contact | Merav Yarmus |
| Correspondent | Merav Yarmus LUMENIS LTD. 155 BIALIK STREET Ramat Gan, IL 5252346 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143453 | K140388 | 000 |
| 07290109140230 | K140388 | 000 |
| 07290109140223 | K140388 | 000 |
| 17290109140213 | K140388 | 000 |
| 17290109140206 | K140388 | 000 |
| 17290109140190 | K140388 | 000 |
| 17290109140183 | K140388 | 000 |
| 17290109140176 | K140388 | 000 |
| 17290109140169 | K140388 | 000 |
| 07290109140124 | K140388 | 000 |
| 07290109140049 | K140388 | 000 |
| 07290109140032 | K140388 | 000 |
| 07290109140025 | K140388 | 000 |
| 07290109140018 | K140388 | 000 |
| 07290109140247 | K140388 | 000 |
| 07290109140254 | K140388 | 000 |
| 07290109140261 | K140388 | 000 |
| 07290109143408 | K140388 | 000 |
| 17290109143221 | K140388 | 000 |
| 17290109143214 | K140388 | 000 |
| 17290109143207 | K140388 | 000 |
| 17290109143191 | K140388 | 000 |
| 17290109143184 | K140388 | 000 |
| 07290109143170 | K140388 | 000 |
| 17290109143061 | K140388 | 000 |
| 17290109142101 | K140388 | 000 |
| 07290109142050 | K140388 | 000 |
| 17290109140718 | K140388 | 000 |
| 17290109140701 | K140388 | 000 |
| 07290109140278 | K140388 | 000 |
| 07290109140001 | K140388 | 000 |