# K083733: Lume 2 System, Model GA0005000

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: May 4, 2009 after 139 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: 14 generations back to K943450 (1995). 121 ancestors in all.
39 later devices descend from it; 1 cites it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060448: Lumenis One Family of Systems; Lumenis One., Lumenis, Ltd. (2006) Summary page 1.

## Most influential descendants
- K142860: Lumenis M22 System (2015), 38 descendants of its own
- K170060: M22 and ResurFx Systems (2017), 24 descendants of its own
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System (2020), 12 descendants of its own
- K203441: The Alma Hybrid Laser System (2021), 5 descendants of its own
- K202884: SR-1 Skin Treatment System (2021), 4 descendants of its own

## Indications for use
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos. Cutaneous lesions, including warts, scars and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles. with Nd:YAG laser at wavelength 1064 nm, is indicated for: The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The non-ablative treatment of facial wrinkles. 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/K083733
Methodology: https://510kreport.com/methodology