# K162371: Pulsaderm ACE-All Blue

- Pathway: 510(k) (Traditional)
- Applicant: Nutra Luxe MD, LLC
- Decided: Dec 15, 2016 after 113 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: 4 generations back to K982082 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132838: Nutra Light Blue, Nutra Luxe MD, LLC (2014) Summary page 5.
- K124042: Tanda Mini Skincare System, Syneron Beauty (2013) Summary page 4.

## Indications for use
Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.

Source page: https://510kreport.com/device/K162371
Methodology: https://510kreport.com/methodology