The following data is part of a premarket notification filed by Nuvolase, Inc. with the FDA for Pinpointe Footlaser.
| Device ID | K130413 |
| 510k Number | K130413 |
| Device Name: | PINPOINTE FOOTLASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NUVOLASE, INC. 26 REBECCA CT Homosassa, FL 34446 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor NUVOLASE, 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 | 2013-02-19 |
| Decision Date | 2013-03-21 |
| Summary: | summary |