The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Greenlight Xps Laser System.
| Device ID | K092735 |
| 510k Number | K092735 |
| Device Name: | GREENLIGHT XPS LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 155-A MOFFETT PARK DR. SUITE 210 Sunnyvale, CA 94089 |
| Contact | Darlene-crocket Billig |
| Correspondent | Darlene-crocket Billig AMERICAN MEDICAL SYSTEMS, INC. 155-A MOFFETT PARK DR. SUITE 210 Sunnyvale, CA 94089 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2009-11-09 |
| Summary: | summary |