Device details
FDA 510(k) registration fields
- K number
- K221789
- Device name
- IRIS Pi Q switched Nd YAG laser
- Company
- Bio-Med USA, Inc.
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-06-21
- Decision date
- 2022-08-09
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingPigment treatmentVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
