Device details
FDA 510(k) registration fields
- K number
- K161670
- Device name
- Lucid Q-PTP / HWA 55
- 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
- 2016-06-16
- Decision date
- 2016-11-02
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingPigment treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
