Device details
FDA 510(k) registration fields
- K number
- K250384
- Device name
- IPL400
- Company
- El Global Trade, Ltd.
- Country / region
- United States(US)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-02-11
- Decision date
- 2025-05-23
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- ArmsLegsOther
- Primary application
- Other
- Classification source
- AI classified
