VAPORMAX
Powered Laser Surgical Instrument
TRIMEDYNE, INC.
The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Vapormax.
Pre-market Notification Details
| Device ID | K050412 |
| 510k Number | K050412 |
| Device Name: | VAPORMAX |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 15091 BAKE PKWY. Irvine, CA 92618 |
| Contact | Glenn Yeik |
| Correspondent | Morten S 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 | 2005-02-18 |
| Decision Date | 2005-03-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816959021627 | K050412 | 000 |
Trademark Results [VAPORMAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAPORMAX 87797553 5503242 Live/Registered |
Nike, Inc. 2018-02-14 |
 VAPORMAX 86714006 5046753 Live/Registered |
HEALTHIER CHOICES MANAGEMENT CORP. 2015-08-04 |
 VAPORMAX 86635628 not registered Dead/Abandoned |
Georgia-Pacific Corrugated LLC 2015-05-20 |
 VAPORMAX 85215606 3998191 Live/Registered |
HEALTHIER CHOICES MANAGEMENT CORP. 2011-01-12 |
 VAPORMAX 75938943 2756605 Live/Registered |
Trimedyne, Inc. 2000-03-08 |
 VAPORMAX 75060196 not registered Dead/Abandoned |
Surgical Laser Technologies, Inc. 1996-02-20 |
 VAPORMAX 74590278 1925076 Dead/Cancelled |
AMERIVAP SYSTEMS, INC. 1994-10-25 |
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