Endo-Lase Cd-100 CO2 Laser for Neurosurgery
510(k) K853878
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853878 | Date2 May 1986 | 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- Withdrawn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, 19 Sep 2026
The Endo-Lase CD-100 CO₂ Laser for Neurosurgery is a carbon dioxide (CO₂) laser system designed for precise tissue ablation, coagulation, and vaporisation in neurosurgical procedures. It operates within the CO₂ wavelength range, enabling controlled cutting and sealing of neural tissues while minimising thermal damage to surrounding structures.
This device is supplied as a reusable medical instrument, intended for use in sterile operating environments by trained neurosurgeons. It requires proper handling, calibration, and maintenance as outlined in the manufacturer’s instructions to ensure safe and effective performance. The Endo-Lase CD-100 holds an FDA 510(k) clearance under product code GEX, with a decision date of May 2, 1986, and is classified under the General and Plastic Surgery advisory committee.