Class Class II
IPL400 (K250384)
Description
IPL400 by El Global Trade, Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250384
Clearance Date2025-05-23
Clearance TypeTraditional
Product CodeOHT
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250384
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. IPL400 (K250384) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01... | Shenzhen Ulike Smart Electronics Co... | 2025 |
| K242039 | Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UI... | Shenzhen Ulike Smart Electronics Co... | 2024 |
| K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | Shenzhen Jianrong Biomedical Electr... | 2024 |
| K130315 | IPULSE HAIR REMOVAL SYSTEM | Cyden Limited | 2013 |
Trace the full predicate network for K250384
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.