# K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Oct 11, 2002 after 210 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: 5 generations back to K910422 (1992). 49 ancestors in all.
1,046 later devices descend from it; 21 cite it directly.
0 of 1,096 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 1.
- K994014: Esc Intense Pulsed Light Systems: Epilight and Multilight, Esc Medical Systems, Ltd. (2000) Summary page 1.
- K980537: ND: Yag Accessory for Photoderm System, Esc Medical Systems, Ltd. (1998) Summary page 1.
- K960772: Photoderm PL., Esc Medical Systems, Ltd. (1996) Summary page 1.
- K950493: Photoderm VL., Esc, Energy Systems Corp. (1995) Summary page 1.
- K011092: Candela SPTL-1E Pulsed Dye Laser, Candela Corp. (2001)
- K001589: Candela Dynamic Cooling Device, Candela Corp. (2000)
- K951033: Andela Dynamic Cooling Device, Candela Laser Corp. (1996) Summary page 1.
- K000503: Medart 520 Cooling System, Medart Corp. (2000) Summary page 1.
- K990417: Dermacool, Optomed Corp. (1999) Summary page 1.
- K960032: Coherent Versapulse Aesthetic Surgical Lasers, Coherent Medical Group (1996) Summary page 1.

## Most influential descendants
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems (2003), 756 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own
- K032460: Profile BBL System (2003), 569 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 nm): The 515 - 1200 nm intense pulsed light wavelengths are indicated for: The treatment of tattoos and benign pigmented epidermal and 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, melasma, 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 permanerd, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Nd:YAG Laser Wavelength (1064 nm): The 1064 nm wavelength produced by the Nd:YAG laser 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. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen. Real Time Chiller: 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/K020839
Methodology: https://510kreport.com/methodology