Class Class II
Infrared Heat (Model: E0221) (K223893)
Description
Infrared Heat (Model: E0221) by Light Tree Ventures Europe B.V., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223893
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223893
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. Infrared Heat (Model: E0221) (K223893) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201107 | Opera Lebody (Gold), Opera Lebody (Zafiro) | Gtg Wellness Co., Ltd. | 2020 |
| K171323 | BIOPHOTAS CELLUMA3 | Biophotas, Inc. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242151 | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C,... | Shenzhen Nuon Medical Equipment Co.... | 2025 |
Trace the full predicate network for K223893
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.