The following data is part of a premarket notification filed by American Medical Systems with the FDA for Sureflex Lithotripsy Laser Fibers.
| Device ID | K140679 |
| 510k Number | K140679 |
| Device Name: | SUREFLEX LITHOTRIPSY LASER FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMERICAN MEDICAL SYSTEMS 3070 ORCHARD DRIVE San Jose, CA 95134 |
| Contact | Josh Clarin |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-06-20 |
| Summary: | summary |