# K040659: Mccue PLC Energist Ultra Variable Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Mccue Plc
- Decided: Jun 1, 2004 after 81 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). 59 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 71 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 1.
- K020856: Spatouch Photoepilation System, Radiancy (Israel), Ltd. (2002) Summary page 1.
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K020941: Palomar Luxg Handpiece, Palomar (2002) Summary page 1.
- K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos, Medical Bio Care Sweden AB (2002) Summary page 1.
- K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair, Medical Bio Care Sweden AB (2002) Summary page 1.
- K023081: Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction), Medical Bio Care Sweden AB (2002) Summary page 1.

## Most influential descendants
- K060234: Mccue Energist Ultra VPL Intense Pulse Light System (2006), 8 descendants of its own
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own

## Indications for use
The McCue Energist ULTRA TM VPL Intense Pulsed Light System is intended for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions. * Intense Pulsed light Energy / wavelengths (530 - 950nm) The 530-950nm intense pulsed wavelengths are indicated for: The treatment of 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 angiormas, poikiloderma of Civatte, leg veins, facial veins and venous malformations. * Intense Pulsed light Energy / wavelengths (610- 950nm) The 610-950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types, and to effect stable long-term or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

Source page: https://510kreport.com/device/K040659
Methodology: https://510kreport.com/methodology