The following data is part of a premarket notification filed by Patholase, Inc with the FDA for Patholase Family Of Pinpointe And Pinpointe Footlaser Nd: Yag Lasers.
| Device ID | K083616 |
| 510k Number | K083616 |
| Device Name: | PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PATHOLASE, INC 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden PATHOLASE, INC 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 | 2008-12-08 |
| Decision Date | 2009-06-12 |
| Summary: | summary |