The following data is part of a premarket notification filed by Incisive, Inc. (formerly Named Incisive, Llc) with the FDA for Pinpointe Footlaser Model 6w, 30w, 100w.
| Device ID | K093545 |
| 510k Number | K093545 |
| Device Name: | PINPOINTE FOOTLASER MODEL 6W, 30W, 100W |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2010-10-15 |
| Summary: | summary |