LIGHTSHEER
Powered Laser Surgical Instrument
PALOMAR MEDICAL PRODUCTS, INC.
The following data is part of a premarket notification filed by Palomar Medical Products, Inc. with the FDA for Lightsheer.
Pre-market Notification Details
| Device ID | K980420 |
| 510k Number | K980420 |
| Device Name: | LIGHTSHEER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL PRODUCTS, INC. 45 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Steven Armstrong |
| Correspondent | Steven Armstrong PALOMAR MEDICAL PRODUCTS, INC. 45 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-03 |
| Decision Date | 1998-05-04 |
| Summary: | summary |
Trademark Results [LIGHTSHEER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIGHTSHEER 78076326 2639704 Dead/Cancelled |
LUMENIS, LTD. 2001-07-30 |
 LIGHTSHEER 78072315 not registered Dead/Abandoned |
ESC MEDICAL SYSTEMS LTD. 2001-07-04 |
 LIGHTSHEER 77852496 3875752 Live/Registered |
Lumenis, Ltd. 2009-10-20 |
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