Device details
FDA 510(k) registration fields
- K number
- K160227
- Device name
- ACCENTO / HWA Dual/Single laser
- Company
- Bison Medical Co, Ltd.
- Country / region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-01-29
- Decision date
- 2016-04-22
- Submission type
- Traditional
- Technology type
- Alexandrite(AI inferred)
- Clinical applications
- Hair removalPigment treatmentVascular treatmentSkin tightening
- Primary application
- Hair removal
- Classification source
- AI classified
