DERMIUM
Powered Laser Surgical Instrument
PREMIER LASER SYSTEMS, INC.
The following data is part of a premarket notification filed by Premier Laser Systems, Inc. with the FDA for Dermium.
Pre-market Notification Details
| Device ID | K980561 |
| 510k Number | K980561 |
| Device Name: | DERMIUM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PREMIER LASER SYSTEMS, INC. 3 MORGAN Irvine, CA 92718 |
| Contact | Lisa Mojica |
| Correspondent | Lisa Mojica PREMIER LASER SYSTEMS, INC. 3 MORGAN Irvine, CA 92718 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-13 |
| Decision Date | 1998-03-19 |
Trademark Results [DERMIUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DERMIUM 85093783 3937623 Dead/Cancelled |
DERMIUM, S.A. DE C.V. 2010-07-27 |
 DERMIUM 75458345 2279014 Dead/Cancelled |
Premier Laser Systems, Inc. 1998-03-27 |
 DERMIUM 73284912 1221396 Dead/Cancelled |
Elbe Distributors, Inc. 1980-11-06 |
 DERMIUM 71510966 0433990 Dead/Expired |
MIFFLIN CHEMICAL COMPANY 1946-10-16 |
 DERMIUM 71507684 0432657 Dead/Expired |
MIFFLIN CHEMICAL COMPANY 1946-08-20 |
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