# K123999: Illumask Acne Light Therapy Mask

- Pathway: 510(k) (Traditional)
- Applicant: La Lumiere, LLC
- Decided: Aug 28, 2013 after 245 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: 10 generations back to K943450 (1995). 87 ancestors in all.
112 later devices descend from it; 3 cite it directly.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081307: Omnilux Clear-U, Photo Therapeutics, Inc. (2009) Summary page 1.

## Most influential descendants
- K140471: Pro X Otc 5 (2015), 107 descendants of its own
- K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 (2017), 106 descendants of its own
- K170984: LG Beauty Led Mask (2017), 93 descendants of its own
- K191629: faceLITE (2019), 71 descendants of its own
- K171323: Biophotas CELLUMA3 (2017), 56 descendants of its own

## Indications for use
The illuMask Acne Light Therapy Mask is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.

Source page: https://510kreport.com/device/K123999
Methodology: https://510kreport.com/methodology