510(k) · Cleared
ClearedPalomar Estelux Pulsed Light System and Palomar Coolroller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 10, 2002 as substantially equivalent to K991935 (Esc Medical Systems, Ltd., 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 1992. 1,018 later devices descend from it.
- Decided
- May 10, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K910422 (1992). 18 ancestors in all, the oldest K892514 (1990). 1,018 later devices descend from it, 15 citing it directly.
- Root · 5 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 4 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 3 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 2 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 1 generation backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- This deviceK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 569 of its ownK032460 Profile BBL SystemSciton, Inc · 2003
- Descendant · cites it directly · 563 of its ownK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
Showing 5 of 1,018 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,018 · See all- K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
- K032460Profile BBL SystemSciton, Inc · 2003 · cites it directly569descendants
- K030426Omnilux RedPhoto Therapeutics Limited · 2003 · cites it directly563descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 2 generations on402descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −4 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −3 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −2 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −1 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| 0 (this device) | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| +1 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 16 | 0 |
| 2006 | 20 | 0 |
| 2007 | 25 | 0 |
| 2008 | 38 | 0 |
| 2009 | 23 | 0 |
| 2010 | 26 | 0 |
| 2011 | 24 | 0 |
| 2012 | 21 | 0 |
| 2013 | 33 | 0 |
| 2014 | 36 | 0 |
| 2015 | 41 | 0 |
| 2016 | 47 | 0 |
| 2017 | 51 | 0 |
| 2018 | 45 | 0 |
| 2019 | 36 | 0 |
| 2020 | 51 | 0 |
| 2021 | 48 | 0 |
| 2022 | 74 | 0 |
| 2023 | 64 | 0 |
| 2024 | 91 | 0 |
| 2025 | 124 | 0 |
| 2026 | 72 | 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? (2)
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 |
|---|---|---|---|
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 1…lRoller™ Laser surgical instrument for use in General and Plastic Surgery and in Dermatology (see: 21 CFR 878-4810). Product Code: GEX Panel: 79 ESC IPL Quantum HR; K991935 Laserscope CoolSpot™; K984110 The EsteLux™ is a light-based medical device designed for permanent hair reduction, effective remo… | 2000 |
| * | K984110 | Laserscope CoolspotSummary page 1…ument for use in General and Plastic Surgery and in Dermatology (see: 21 CFR 878-4810). Product Code: GEX Panel: 79 ESC IPL Quantum HR; K991935 Laserscope CoolSpot™; K984110 The EsteLux™ is a light-based medical device designed for permanent hair reduction, effective removal of unwanted hair, treatmen… | 1998 |
What descends from it? (1,018)
See all 1,01815 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033946 | Lovely System | 2004 | 737 |
| K032460 | Profile BBL System | 2003 | 569 |
| K030426 | Omnilux Red | 2003 | 563 |
| K043329 | Omnilux Revive and Blue | 2005 | 202 |
| K043255 | Ellipse Light SPT | 2005 | 25 |
| K043319 | Clareon and Solarus Pulsed Light Devices and Accessories | 2004 | 15 |
| K040659 | Mccue PLC Energist Ultra Variable Pulsed Light System | 2004 | 11 |
| K041554 | Aip Intense Pulsed Light System | 2005 | 9 |
| K030480 | L600 Hair Removal | 2003 | 1 |
| K061720 | Cosmelight | 2007 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K033946 (Msq (M2), Ltd., 2004) has gone furthest, with 737 descendants of its own.
- 9 other devices also cite its predicate K991935.
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 EsteLux™ Pulsed Light system is intended to for permanent bair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
The CoolRoller™ is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce pain and patient discomfort associated with light applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020453
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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