The following data is part of a premarket notification filed by Monteris Medical with the FDA for Monteris Medical Autolitt Laser Probe.
| Device ID | K081509 |
| 510k Number | K081509 |
| Device Name: | MONTERIS MEDICAL AUTOLITT LASER PROBE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MONTERIS MEDICAL 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs MONTERIS MEDICAL 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2009-05-01 |
| Summary: | summary |