510(k) · Cleared
ClearedElite iQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, LLC · GEX Powered Laser Surgical Instrument
Cleared on Mar 9, 2020 as substantially equivalent to K141425 (Cynosure, Inc., 2014) and 2 other predicates after a 90-day review. Its family tree reaches back 19 generations to 1995. 1 later device descends from it.
- Decided
- Mar 9, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K943450 (1995). 348 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- 2 generations backK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- 1 generation backK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- This deviceK193426 Elite iQCynosure, LLC · 2020
- Descendant · cites it directly · 0 of its ownK240396 Elite iQ PRO (M122K1)Cynosure, LLC · 2024
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 6 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 5 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 4 generations backK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
- 3 generations backK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- 2 generations backK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- 1 generation backK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- This deviceK193426 Elite iQCynosure, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K240396Elite iQ PRO (M122K1)Cynosure, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −6 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −5 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −4 | K082039 | Synchro HP Platform | El.En Electronic Engineering Spa | 2009 | — |
| −3 | K103288 | Deka Synchro FT | El.En Electronic Engineering Spa | 2011 | — |
| −2 | K131095 | Deka Synchro Repla: Y Family of Laser Systems | El.En Electronic Engineering Spa | 2013 | — |
| −1 | K150516 | Deka Synchro Repla:Y Family of Laser Systems | El.En Electronic Engineering Spa | 2015 | — |
| 0 (this device) | K193426 | Elite iQ | Cynosure, LLC | 2020 | — |
| +1 | K240396 | Elite iQ PRO (M122K1) | Cynosure, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 16 | 0 |
| 1995 | 16 | 0 |
| 1996 | 21 | 0 |
| 1997 | 24 | 0 |
| 1998 | 20 | 0 |
| 1999 | 13 | 0 |
| 2000 | 25 | 0 |
| 2001 | 26 | 0 |
| 2002 | 35 | 0 |
| 2003 | 33 | 0 |
| 2004 | 18 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K141425 | Elite + Laser SystemSummary page 4…II Product Code(s) GEX 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed Cynosure Elite+ (K141425) Predicate Devices Deka Synchro Repla:Y (K150516) Cynosure Vectus (K120622) 807.92(a)(4)… | 2014 |
| * | K150516 | Deka Synchro Repla:Y Family of Laser SystemsSummary page 4…)(3) Legally marketed device(s) to which equivalence is claimed Cynosure Elite+ (K141425) Predicate Devices Deka Synchro Repla:Y (K150516) Cynosure Vectus (K120622) 807.92(a)(4) Device Description The Elite i… | 2015 |
| * | K120622 | Palomar Vectus LaserSummary page 4…claimed Cynosure Elite+ (K141425) Predicate Devices Deka Synchro Repla:Y (K150516) Cynosure Vectus (K120622) 807.92(a)(4) Device Description The Elite iQ™ workstation is a dual wavelength system that… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240396 | Elite iQ PRO (M122K1) | 2024 | 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 25 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 14 of the 348 ancestors have a recall of any class.
- Of its descendants, K240396 (Cynosure, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K141425.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Elite iQ Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. The Elite iQ Laser…
Read the full statement (255 words)
The Elite iQ Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
The Elite iQ Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider veins and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Skintel 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193426: Elite iQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193426
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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