# K223893: Infrared Heat (Model: E0221)

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: May 16, 2023 after 139 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 96 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171323: Biophotas CELLUMA3, Biophotas, Inc. (2017) Summary page 4.
- K201107: Opera Lebody (Gold), Opera Lebody (Zafiro), Gtg Wellness Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (2026), 1 descendant of its own
- K242151: Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (2025), 1 descendant of its own
- K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (2026), 0 descendants of its own
- K252603: HIGHERDOSE Body Sculptor (Model: GS-03) (2026), 0 descendants of its own
- K251781: Kala Mini 2.0 (Kala-04) (2025), 0 descendants of its own

## Indications for use
The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.

Source page: https://510kreport.com/device/K223893
Methodology: https://510kreport.com/methodology