The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Vapormax Ii.
| Device ID | K053457 |
| 510k Number | K053457 |
| Device Name: | VAPORMAX II |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 15091 BAKE PKWY. Irvine, CA 92618 |
| Contact | Glenn D Yeik |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-12-13 |
| Decision Date | 2005-12-21 |
| Summary: | summary |