BURANE
by Wavelight Laser Technologie AG
510(k) K052806
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052806 | Date17 Oct 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
BURANE is an Er:YAG laser system designed for dermatological interventions and aesthetic laser applications. It features triple mode technology including a controllable Coagulation Mode for different coagulation depths, an Ablation Mode for classical ablation procedures, and a combination of both modes.
The device is supplied by Wavelight Laser Technologie AG and has received FDA 510(k) clearance with K number K052806. It is intended for use in general and plastic surgery applications. The device is manufactured in Erlangen, Germany, and is authorized for use in dermatological and aesthetic procedures.