# K170111: Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

- Pathway: 510(k) (Traditional)
- Applicant: Pulsaderm, LLC
- Decided: May 8, 2017 after 116 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: 11 generations back to K943450 (1995). 88 ancestors in all.
45 later devices descend from it; 1 cites it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123999: Illumask Acne Light Therapy Mask, La Lumiere, LLC (2013) Summary page 4.

## Most influential descendants
- K180847: Neutrogena Light Therapy Acne Mask+ (2018), 44 descendants of its own
- K190443: MMSphere (2019), 42 descendants of its own
- 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

## Indications for use
The Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are intended for over the counter use for the treatment of mild to moderate acne.

Source page: https://510kreport.com/device/K170111
Methodology: https://510kreport.com/methodology