The following data is part of a premarket notification filed by American Medical Systems with the FDA for Greenlight Moxy Fiber Optic.
| Device ID | K120870 |
| 510k Number | K120870 |
| Device Name: | GREENLIGHT MOXY FIBER OPTIC |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMERICAN MEDICAL SYSTEMS 3070 ORCHARD DRIVE San Jose, CA 95134 |
| Contact | Doreen Nakamura |
| Correspondent | Doreen Nakamura AMERICAN MEDICAL SYSTEMS 3070 ORCHARD DRIVE San Jose, CA 95134 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-06-15 |
| Summary: | summary |