# K063427: Lumina Intense Pulsed Light (& Laser) System

- Pathway: 510(k) (Traditional)
- Applicant: Lynton Lasers Limited
- Decided: Jul 25, 2007 after 254 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 K910422 (1992). 154 ancestors in all.
No later device cites it as a predicate yet.
0 of 155 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.
- K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004) Summary page 1.

## Indications for use
The LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology, as follows· The LUMINA Intense Pulsed Light (& Laser) System, when using the IPL Handpieces, is indicated for: * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation and ephelides (freckles). * The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, 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 removal. * Indicated for use on all skin types (Fitzpatrick I-IV) The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of: · Benign vascular lesions such as, but not limited to treatment of: > Port wine stains > Hemangiomas > Superficial and deep telangiectasias (venulectasias) > Reticular veins (0.1 - 4.0mm diameter) of the leg > Rosacea > Venus Lake > Leg veins > Spider veins > Poikiloderma of Civatte > Angiomas * The removal of blue or black tattoos (significant reduction in the intensity of black and/or blue/black tattoos) The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of - continued -: * The non-ablative treatment of facial wrinkles, such as, but not limited to: > Periocular wrinkles > Perioral wrinkles * The removal of unwanted hair, for stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. * Removal or lightening of unwanted hair (with and without adjuvant preparation). · Pseudofolliculitis barbae (PFB) · Indicated for use on all skin types (Fitzpatrick -IV) The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 532nm (Long Pulsed and Q-Switched), is indicated for: * Tattoo removal: > Light blue > Yellow > Red * Benign pigmented lesions such as, but not limited to: > Caf6 au lait macules > Lentigines (senile and solar) > Freckles (ephelides) > Chloasma > Nevi > Nevus spillus > Nevus of Ota > Becker's nevi

Source page: https://510kreport.com/device/K063427
Methodology: https://510kreport.com/methodology