510(k) · Cleared
ClearedPalomar Icon (TM) Aesthetic System
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 Jun 22, 2011 as substantially equivalent to K100270 (Palomar Medical Technologies, Inc., 2010) and 5 other predicates after an 83-day review. Its family tree reaches back 16 generations to 1992. 57 later devices descend from it.
- Decided
- Jun 22, 2011
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 16 generations to K910422 (1992). 250 ancestors in all, the oldest K820106 (1982). 57 later devices descend from it, 6 citing it directly.
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations between
- 3 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 2 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 1 generation backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- This deviceK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- Descendant · cites it directly · 41 of its ownK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- Descendant · 2 generations on · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 24 of its ownK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- Descendant · cites it directly · 13 of its ownK142376 Palomar Icon Aesthetic SystemCynosure, Inc. · 2014
- Descendant · 3 generations on · 12 of its ownK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
Show all 16 generations
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 15 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 14 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 13 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 12 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 11 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 10 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 9 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 8 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 7 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 6 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 5 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 4 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 3 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 2 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 1 generation backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- This deviceK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K130028Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013 · cites it directly41descendants
- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · 2 generations on38descendants
- K170060M22 and ResurFx SystemsLumenis, Ltd. · 2017 · 2 generations on24descendants
- K142376Palomar Icon Aesthetic SystemCynosure, Inc. · 2014 · cites it directly13descendants
- K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −15 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −13 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −12 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −11 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −10 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −9 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −8 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −7 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −6 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −5 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −4 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −3 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −2 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −1 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| 0 (this device) | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| +1 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| +2 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| +2 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| +1 | K142376 | Palomar Icon Aesthetic System | Cynosure, Inc. | 2014 | — |
| +3 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1993 | 8 | 0 |
| 1994 | 13 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 15 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 18 | 0 |
| 2001 | 22 | 0 |
| 2002 | 27 | 0 |
| 2003 | 23 | 0 |
| 2004 | 13 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K100270 | Artisan Aesthetic SystemSummary page 1…CODES: GEX, ONG 3. PREDICATE DEVICES Palomar Medical Technologies, Inc. Artisan System (Luxl1540, Luxl144O, Lux2940, MaxG) Ki100270 Palomar Medical Technologies, Inc. Combination Fractional Treatnment (Lux1540, Luxl44O, Lux2940) K10… | 2010 |
| * | K101506 | LUX1540, LUX1440 & LUX2940 Laser HandpiecesSummary page 1…0, Luxl144O, Lux2940, MaxG) Ki100270 Palomar Medical Technologies, Inc. Combination Fractional Treatnment (Lux1540, Luxl44O, Lux2940) K101506 Palomar Medical Technologies, Inc. Lux 1064 Handpiece K041 879 Palomar Medical Technologies, Inc.… | 2010 |
| * | K041879 | Palomar LUX1064 HandpieceSummary page 1…c. Combination Fractional Treatnment (Lux1540, Luxl44O, Lux2940) K101506 Palomar Medical Technologies, Inc. Lux 1064 Handpiece K041 879 Palomar Medical Technologies, Inc. LuxIR Handpiece K070298 PALOMAR MEDICAL TECHNOLOGIES, INC.… | 2005 |
| * | K070298 | Modification to Palomar Luxir HandpieceSummary page 1…K101506 Palomar Medical Technologies, Inc. Lux 1064 Handpiece K041 879 Palomar Medical Technologies, Inc. LuxIR Handpiece K070298 PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE 1 OF 3 PALOMAR ICON AESTHETIC SYSTEM === Page 2 =… | 2007 |
| * | K041086 | Palomar Starlux Pulsed Light SystemSummary page 2…Palomar Medical Technologies, Inc. A 7 Palomar StarLux System Intense Pulsed Light Handpieces K041086, K033549 4. INTENDED USE The 2940 Ablative Laser Handpiece is intended for use in surgical applications requirin… | 2005 |
| * | K033549 | Starlux Pulsed Light SystemSummary page 2…2 === Palomar Medical Technologies, Inc. A 7 Palomar StarLux System Intense Pulsed Light Handpieces K041086, K033549 4. INTENDED USE The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the exc… | 2004 |
What descends from it? (57)
See all 576 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 19 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 8 of the 250 ancestors have a recall of any class.
- Of its descendants, K130028 (Lumenis, Ltd., 2013) has gone furthest, with 41 descendants of its own.
- 4 other devices also cite its predicate K100270.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal…
Read the full statement (602 words)
The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.
The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540 Fractional Non-ablative Laser 1-andpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The 1540 Fractional Non-ablative Laser and 2940 Fractional Ablative Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The 1440 Fractional Non-ablative Laser Handpiece and 2940 Fractional Ablative Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The MaxIR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments; treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB3).
The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types 1-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
The SkintelTM Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110907: Palomar Icon (TM) Aesthetic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110907
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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