IPL400
510(k) K250384
IPL400 is a medical device (FDA Class II; FDA product code OHT, Light Based Over-The-Counter Hair Removal) made by El Global Trade Ltd, cleared under FDA 510(k) K250384 on 23 May 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250384 | Date23 May 2025 | StatusActive |
Official records
- FDA 510(k) database K250384
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OHT
- FDA applicant
- El Global Trade, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code OHT (Light Based Over-The-Counter Hair Removal).
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