# K043575: Dermillume, Model PRO1000

- Pathway: 510(k) (Traditional)
- Applicant: Care Electronics, Inc.
- Decided: Feb 24, 2005 after 59 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: 9 generations back to K943450 (1995). 86 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002) Summary page 1.
- K031805: Blu-U, Model 4170, Dusa Pharmaceuticals, Inc. (2003) Summary page 2.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 2.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 2.

## Most influential descendants
- K051681: Dermillume Red, Model HR1000 (2005), 3 descendants of its own
- K081570: DPL Therapy System (2008), 1 descendant of its own
- K150554: NuBrilliance Light Pain Therapy (2015), 0 descendants of its own
- K070690: The Life Vessel (2007), 0 descendants of its own

## Indications for use
The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K043575
Methodology: https://510kreport.com/methodology