Device details
FDA 510(k) registration fields
- K number
- K183392
- Device name
- PicoLO Nd:YAG Picosecond Laser System
- 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
- 2018-12-07
- Decision date
- 2019-01-04
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
