Models 4000, 4900, 6000, 8000, 8900, Luxus 60, 100 & 1700 - 100
510(k) K902061
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902061 | Date10 Jul 1990 | 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- Withdrawn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, 18 Sep 2026
This device is a Powered Laser Surgical Instrument, classified under the GEX product code. It is designed for surgical procedures involving laser energy, including applications in general and plastic surgery. The device utilizes Nd:YAG and CO₂ laser technologies to deliver precise, controlled energy for tissue ablation, coagulation, or vaporization.
The Models 4000, 4900, 6000, 8000, 8900, Luxus 60, 100 & 1700 are intended for reusable use in clinical settings. They hold FDA 510(k) clearance (K902061, K883379, K894164) under the General and Plastic Surgery advisory committees. Sterility and maintenance protocols must adhere to manufacturer guidelines, and compatibility with MRI environments should be verified per device specifications.