Device details
FDA 510(k) registration fields
- K number
- K162416
- Device name
- IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
- Company
- Iridex Corporation
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-08-30
- Decision date
- 2016-09-29
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
