LATERALASE
Powered Laser Surgical Instrument
TRIMEDYNE, INC.
The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Lateralase.
Pre-market Notification Details
| Device ID | K915354 |
| 510k Number | K915354 |
| Device Name: | LATERALASE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
| Contact | Paul Kramsky |
| Correspondent | Paul Kramsky TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-02-24 |
Trademark Results [LATERALASE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LATERALASE 74159126 2557504 Dead/Cancelled |
Trimedyne Inc. 1991-04-15 |
 LATERALASE 74105660 not registered Dead/Abandoned |
Everett, Royice B. 1990-10-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.