KERATOLUX
Device, Fixation, Ac-powered, Ophthalmic
CARL ZEISS, INC.
The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Keratolux.
Pre-market Notification Details
| Device ID | K854383 |
| 510k Number | K854383 |
| Device Name: | KERATOLUX |
| Classification | Device, Fixation, Ac-powered, Ophthalmic |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Marie Pederson |
| Correspondent | Marie Pederson CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | HPL |
| CFR Regulation Number | 886.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-30 |
| Decision Date | 1985-11-12 |
Trademark Results [KERATOLUX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KERATOLUX 78411527 2970432 Live/Registered |
VIRBAC AH, INC. 2004-04-30 |
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