The following data is part of a premarket notification filed by Incisive Inc. with the FDA for Inpulse Laser.
| Device ID | K131805 |
| 510k Number | K131805 |
| Device Name: | INPULSE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INCISIVE INC. 26 REBECCA CT Homosassa, FL 34446 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor INCISIVE INC. 26 REBECCA CT Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-19 |
| Decision Date | 2013-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860367000309 | K131805 | 000 |