BURANE
Powered Laser Surgical Instrument
WAVELIGHT LASER TECHNOLOGIE AG
The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Burane.
Pre-market Notification Details
| Device ID | K052806 |
| 510k Number | K052806 |
| Device Name: | BURANE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WAVELIGHT LASER TECHNOLOGIE AG AM WOLFSMANTEL 5 Erlangen, DE 91058 |
| Contact | Alexander Popp |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2005-10-17 |
| Summary: | summary |
Trademark Results [BURANE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BURANE 79007776 3181081 Dead/Cancelled |
Alma Lasers Ltd. 2004-10-05 |
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