# K053324: Chromolite System

- Pathway: 510(k) (Traditional)
- Applicant: Chromogenex Plc
- Decided: Jan 5, 2006 after 35 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: 8 generations back to K910422 (1992). 86 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033946: Lovely System, Msq (M2), Ltd. (2004) Summary page 1.

## Most influential descendants
- K082484: Accelawave System (2008), 29 descendants of its own
- K093627: Ipulselight Ipl System, Models HS 300C and HS 650 (2011), 24 descendants of its own
- K122995: Intense Pulsed Light (Ipl) Systems (2013), 16 descendants of its own
- K200746: IPL Treatment Systems (2020), 5 descendants of its own
- K161286: IPL Therapy Machine (2016), 5 descendants of its own

## Indications for use
Indications for Use for Fitzpatrick skin types (I to V) The treatment of moderate inflammatory acne vulgaris The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) The treatment of cutaneous lesions including wads, scars, and striae. The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

Source page: https://510kreport.com/device/K053324
Methodology: https://510kreport.com/methodology