Device details
FDA 510(k) registration fields
- K number
- K250165
- Device name
- Pastelle
- Company
- Wontech Co., Ltd.
- Country / region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-21
- Decision date
- 2025-07-03
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingPigment treatmentHair removalSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
