Device details
FDA 510(k) registration fields
- K number
- K212573
- Device name
- PicoLO Premium
- Company
- Laseroptek Co., Ltd.
- Country / region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-08-16
- Decision date
- 2021-12-08
- Submission type
- Special
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
