ORBSCAN
Device, Analysis, Anterior Segment
TECHNOLAS PERFECT VISION GMBH
The following data is part of a premarket notification filed by Technolas Perfect Vision Gmbh with the FDA for Orbscan.
Pre-market Notification Details
| Device ID | K984443 |
| 510k Number | K984443 |
| Device Name: | ORBSCAN |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | TECHNOLAS PERFECT VISION GMBH PO BOX 17190 Anaheim, CA 92817 -7190 |
| Contact | Betsy M Johnson |
| Correspondent | Betsy M Johnson TECHNOLAS PERFECT VISION GMBH PO BOX 17190 Anaheim, CA 92817 -7190 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-03-05 |
| Summary: | summary |
Trademark Results [ORBSCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORBSCAN 75095856 2050811 Live/Registered |
TECHNOLAS PERFECT VISION GMBH 1996-04-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.