# K161941: Pulsaderm Acne Device

- Pathway: 510(k) (Traditional)
- Applicant: Nutra Luxe MD, LLC
- Decided: Oct 19, 2016 after 96 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). 95 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124042: Tanda Mini Skincare System, Syneron Beauty (2013) Summary page 5.
- K123999: Illumask Acne Light Therapy Mask, La Lumiere, LLC (2013) Summary page 5.
- K081307: Omnilux Clear-U, Photo Therapeutics, Inc. (2009) Summary page 5.

## Most influential descendants
- K161434: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) (2017), 3 descendants of its own
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own
- K252272: ORA Method LED Gua Sha (GS-04) (2025), 0 descendants of its own
- K251076: Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) (2025), 0 descendants of its own

## Indications for use
Pulsaderm Acne Device 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/K161941
Methodology: https://510kreport.com/methodology