Device details
FDA 510(k) registration fields
- K number
- K253342
- Device name
- PICO-K
- Company
- Speclipse, Inc.
- Country / region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-09-30
- Decision date
- 2025-12-24
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentAcne treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
