510(k) · Cleared
ClearedMccue PLC Energist Ultra Variable Pulsed Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mccue Plc · GEX Powered Laser Surgical Instrument
Cleared on Jun 1, 2004 as substantially equivalent to K020839 (Lumenis, Inc., 2002) and 7 other predicates after an 81-day review. Its family tree reaches back 6 generations to 1992. 11 later devices descend from it.
- Decided
- Jun 1, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 6 generations to K910422 (1992). 59 ancestors in all, the oldest K892514 (1990). 11 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 4 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 3 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 2 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 1 generation backK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- This deviceK040659 Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc · 2004
- Descendant · cites it directly · 8 of its ownK060234 Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc · 2006
- Descendant · 2 generations on · 6 of its ownK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- Descendant · 3 generations on · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · 4 generations on · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 5 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc · 2006 · cites it directly8descendants
- K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008 · 2 generations on6descendants
- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · 3 generations on4descendants
- K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011 · 4 generations on2descendants
- K181868SHINY RPL SystemIds, Ltd. · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −5 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −3 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −2 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −1 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K040659 | Mccue PLC Energist Ultra Variable Pulsed Light System | Mccue Plc | 2004 | — |
| +1 | K060234 | Mccue Energist Ultra VPL Intense Pulse Light System | Mccue Plc | 2006 | — |
| +2 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| +3 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +4 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +5 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…The McCue Energist ULTRAT M is substantially equivalent to the following Predicate currently marketed devices: Devices: Lumenis, Inc. FPL Quantum, K020839 Radiancy, Inc. SpaTouch, K020856 Radiancy, Inc. Skin Station, K030897… | 2002 |
| * | K020856 | Spatouch Photoepilation SystemSummary page 1…lent to the following Predicate currently marketed devices: Devices: Lumenis, Inc. FPL Quantum, K020839 Radiancy, Inc. SpaTouch, K020856 Radiancy, Inc. Skin Station, K030897 Palomar, Inc. EsteLux, K020453, K020941… | 2002 |
| * | K030897 | SkinstationSummary page 1…ted devices: Devices: Lumenis, Inc. FPL Quantum, K020839 Radiancy, Inc. SpaTouch, K020856 Radiancy, Inc. Skin Station, K030897 Palomar, Inc. EsteLux, K020453, K020941 Alderm/MBC, Prolite/Plasmalite, K013365, K022568,… | 2003 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…Quantum, K020839 Radiancy, Inc. SpaTouch, K020856 Radiancy, Inc. Skin Station, K030897 Palomar, Inc. EsteLux, K020453, K020941 Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081 System The McCue Energist ULT… | 2002 |
| * | K020941 | Palomar Luxg HandpieceSummary page 1…K020839 Radiancy, Inc. SpaTouch, K020856 Radiancy, Inc. Skin Station, K030897 Palomar, Inc. EsteLux, K020453, K020941 Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081 System The McCue Energist ULTRA TM is… | 2002 |
| * | K013365 | Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of…Summary page 1…Radiancy, Inc. Skin Station, K030897 Palomar, Inc. EsteLux, K020453, K020941 Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081 System The McCue Energist ULTRA TM is a light-based medical device that delivers a Description:… | 2002 |
| * | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairSummary page 1…Radiancy, Inc. Skin Station, K030897 Palomar, Inc. EsteLux, K020453, K020941 Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081 System The McCue Energist ULTRA TM is a light-based medical device that delivers a Description: beam… | 2002 |
| * | K023081 | Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Summary page 1…Radiancy, Inc. Skin Station, K030897 Palomar, Inc. EsteLux, K020453, K020941 Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081 System The McCue Energist ULTRA TM is a light-based medical device that delivers a Description: beam of pulse… | 2002 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 59 ancestors has a recall of any class.
- Of its descendants, K060234 (Mccue Plc, 2006) has gone furthest, with 8 descendants of its own.
- 20 other devices also cite its predicate K020839.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (171 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040659 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040659: Mccue PLC Energist Ultra Variable Pulsed Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040659
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026