# K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis
- Decided: May 20, 2003 after 90 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: 6 generations back to K910422 (1992). 50 ancestors in all.
856 later devices descend from it; 6 cite it directly.
0 of 907 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 2.

## Most influential descendants
- K033946: Lovely System (2004), 737 descendants of its own
- K032460: Profile BBL System (2003), 569 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K042630: Revlight Skin Care System (2005), 402 descendants of its own
- K041969: Aurora DS (2004), 302 descendants of its own

## Indications for use
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows: Intense Pulsed Light Energy/ Wavelengths (515 - 1200 run) are indicated for: * The treatment of tattoos; * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); * The treatment of cutaneous lesions including warts, scars and striae; * 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 from all skin types, and to effect stable long-term, or permanent¹, hair reduction in skin types I-V. Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including: * 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, and to effect stable long-term, or permanent¹, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: * Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); * Reduce discomfort during and/or associated with light or laser treatment; * Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation; * Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and * Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Source page: https://510kreport.com/device/K030527
Methodology: https://510kreport.com/methodology