# K201107: Opera Lebody (Gold), Opera Lebody (Zafiro)

- Pathway: 510(k) (Traditional)
- Applicant: Gtg Wellness Co., Ltd.
- Decided: Jun 22, 2020 after 59 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: 13 generations back to K943450 (1995). 94 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72, Pulsaderm, LLC (2017) Summary page 4.
- K133896: Rejuvalite MD, Trophy Skin, Inc. (2014) Summary page 4.

## Most influential descendants
- K223893: Infrared Heat (Model: E0221) (2023), 5 descendants of its own
- K202028: dermalux Flex MD (2020), 5 descendants of its own
- K212275: Dermalux Flex MD (2021), 4 descendants of its own
- K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (2026), 1 descendant of its own
- K251012: TRUDERMAL Pro (ZLD-390) (2025), 1 descendant of its own

## Indications for use
OPERA LEBODY is an over the counter device that is intended for the use in the treatment of full face wrinkles.

Source page: https://510kreport.com/device/K201107
Methodology: https://510kreport.com/methodology