# K100628: Plasmaluxls

- Pathway: 510(k) (Traditional)
- Applicant: Daavlin Distributing Co.
- Decided: Nov 24, 2010 after 264 days
- Product code: ONE (Powered Light Based Non-Laser Surgical Instrument)
- 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.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031805: Blu-U, Model 4170, Dusa Pharmaceuticals, Inc. (2003) Summary page 1.
- K062871: Lumacare LC-122M Non-Coherent Light Source, Lynton Lasers Limited (2006) Summary page 2.
- K082586: Lightwave Professional Deluxe, Lightwave Technologies, LLC (2010). Our reading of the summary gave K083586, FDA’s number for I-Fix System (Dentis Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lightwave Professional Deluxe”.

## Indications for use
The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K100628
Methodology: https://510kreport.com/methodology