Device details
FDA 510(k) registration fields
- K number
- K212082
- Device name
- Picore
- 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
- 2021-07-02
- Decision date
- 2021-10-06
- Submission type
- Special
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
