The following data is part of a premarket notification filed by G.n.s Neolaser Ltd. with the FDA for Neov Diode Laser Family.
| Device ID | K133006 |
| 510k Number | K133006 |
| Device Name: | NEOV DIODE LASER FAMILY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | G.N.S NEOLASER LTD. 7 HA'ESHEL STR Caesarea, IL 38900 |
| Contact | Gil Shapira |
| Correspondent | Gil Shapira G.N.S NEOLASER LTD. 7 HA'ESHEL STR Caesarea, IL 38900 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2014-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016629132 | K133006 | 000 |
| 07290016629019 | K133006 | 000 |
| 07290016629026 | K133006 | 000 |
| 07290016629170 | K133006 | 000 |
| 07290016629040 | K133006 | 000 |
| 07290016629057 | K133006 | 000 |
| 07290016629064 | K133006 | 000 |
| 07290016629071 | K133006 | 000 |
| 07290016629088 | K133006 | 000 |
| 07290016629095 | K133006 | 000 |
| 07290016629101 | K133006 | 000 |
| 07290016629118 | K133006 | 000 |
| 07290016629125 | K133006 | 000 |
| 07290016629149 | K133006 | 000 |