# K210545: Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine

- Pathway: 510(k) (Traditional)
- Applicant: Marci Beauty, Inc.
- Decided: May 20, 2022 after 449 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- 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: 15 generations back to K943450 (1995). 162 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203271: Aduro light therapy Handheld, Shenzhen Kaiyan Medical CO, Ltd. (2021). Cleared while this submission was under review Summary page 4.
- K200983: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine, Ningbo Hesi Electric Co., Ltd. (2021). Cleared while this submission was under review Summary page 4.
- K172909: Elevare, Perfectio 4, Omm Imports D/B/A Zero Gravity (2018) Summary page 4.
- K172555: Sapphire, Elevare Sapphire, Omm Imports, Inc. D/B/A Zero Gravity (2018) Summary page 4.

## Most influential descendants
- K253833: Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (2026), 0 descendants of its own
- K243555: LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) (2025), 0 descendants of its own

## Indications for use
The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.

Source page: https://510kreport.com/device/K210545
Methodology: https://510kreport.com/methodology