# K190443: MMSphere

- Pathway: 510(k) (Traditional)
- Applicant: Galactic Beauty, LLC
- Decided: Jun 24, 2019 after 119 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: 15 generations back to K943450 (1995). 98 ancestors in all.
42 later devices descend from it; 5 cite it directly.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120775: Light for Wrinkles, Led Intellectual Properties, LLC (2012) Summary page 5.
- K180847: Neutrogena Light Therapy Acne Mask+, Johnson & Johnson Consumer, Inc. (2018) Summary page 5.
- K180856: Neutrogena Light Therapy Aging Mask+, Johnson & Johnson Consumer, Inc. (2018) Summary page 5.

## Most influential descendants
- K202390: Aduro Light Beauty Mask (2021), 39 descendants of its own
- K220168: Skin Care Beauty Mask (Model: MJ-06) (2022), 34 descendants of its own
- K230351: LED Facial Mask (2023), 33 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 12 descendants of its own

## Indications for use
MMSphere™ Light Therapy Device emits energy in the red, blue and amber regions of the spectrum, specifically indicated to treat wrinkles and/or mild to moderate acne. The MMSphere™ is designed to be used for 20 minute treatments three to seven times per week.

Source page: https://510kreport.com/device/K190443
Methodology: https://510kreport.com/methodology