Device details
FDA 510(k) registration fields
- K number
- K212073
- Device name
- Alma Diode Tabletop Laser
- Company
- Alma Lasers, Inc.
- Country / region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-07-02
- Decision date
- 2022-07-14
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
