# K170187: Photodynamic Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Uvbiotek, LLC
- Decided: Jul 28, 2017 after 186 days
- Product code: GEX (Powered 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: 12 generations back to K943450 (1995). 132 ancestors in all.
No later device cites it as a predicate yet.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083183: Aklarus Phototherapy System, Hill Laboratories Co. (2009) Summary page 4.

## Indications for use
The Photodynamic Therapy Device combination of Red (633nm=+10nm) and Blue (417nm=10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Source page: https://510kreport.com/device/K170187
Methodology: https://510kreport.com/methodology