# K081619: Chromolite EP

- Pathway: 510(k) (Special)
- Applicant: Chromogenex Technologies Limited
- Decided: Jul 18, 2008 after 39 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Chromolite System: named in the summary without a submission number

## Indications for use
Indications for use for Fitzpatrick skin types (I to V). The Chromolite TM EP System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostatis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:- 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, hyper-pigmentation, melasma, ephelides (freckles) * The treatment of cutaneous lesions including warts,scars, and striae. * The treatment of benign cutaneous vascular lesioins, including port wine stains, hemamangiomas, 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. 1 = 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/K081619
Methodology: https://510kreport.com/methodology