Device details
FDA 510(k) registration fields
- K number
- K191962
- Device name
- Vitra 2
- Company
- Quantel Medical
- Country / region
- France(FR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-07-23
- Decision date
- 2019-12-05
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- OphthalmicVascular treatmentOther
- Primary application
- Ophthalmic
- Classification source
- AI classified
