The following data is part of a premarket notification filed by Incisive, Llc. with the FDA for Incisive Family Of Inpulse Nd:yag Lasers.
| Device ID | K083215 |
| 510k Number | K083215 |
| Device Name: | INCISIVE FAMILY OF INPULSE ND:YAG LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INCISIVE, LLC. 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Contact | Ann Worden |
| Correspondent | Ann Worden 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 | 2008-10-31 |
| Decision Date | 2009-04-08 |
| Summary: | summary |