510(k) · Cleared
ClearedE-Light Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espansione Marketing S.P.A · GEX Powered Laser Surgical Instrument
Cleared on Sep 20, 2010 as substantially equivalent to K070494 (Espansione Marketing S.P.A, 2007) and 8 other predicates after a 381-day review. Its family tree reaches back 16 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 20, 2010
- Review
- 381 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 16 generations to K943450 (1995). 250 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK090762 LEDAQuantel Derma GmbH · 2009
- This deviceK092734 E-Light LineEspansione Marketing S.P.A · 2010
- Descendant · cites it directly · 1 of its ownK124064 Young AgainEspansione Marketing S.P.A · 2013
- Descendant · 2 generations on · 0 of its ownK162556 Lightfusion Led SystemVitage Led, Ltd. · 2017
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK090762 LEDAQuantel Derma GmbH · 2009
- This deviceK092734 E-Light LineEspansione Marketing S.P.A · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −1 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| 0 (this device) | K092734 | E-Light Line | Espansione Marketing S.P.A | 2010 | — |
| +1 | K124064 | Young Again | Espansione Marketing S.P.A | 2013 | — |
| +2 | K162556 | Lightfusion Led System | Vitage Led, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 4 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 17 | 0 |
| 1997 | 21 | 0 |
| 1998 | 14 | 0 |
| 1999 | 8 | 0 |
| 2000 | 22 | 0 |
| 2001 | 22 | 0 |
| 2002 | 30 | 0 |
| 2003 | 19 | 0 |
| 2004 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 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? (9)
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 |
|---|---|---|---|
| * | K070494 | Epi-C PlusSummary page 3…missions: intense pulsed light (IPL), light emitting diode (LED) and aspiration massager (Vacuum). The IPL technology is the same of the Espansione Marketing Epi-c Plus (K070494) both for intended use and for technological characteristics, in fact the E-light line family was developed with the same hardwar… | 2007 |
| * | K073477 | Photonova Family of Pulsed Light SystemsSummary page 3…with the same hardware of the Espansione Marketing Fpi-c Plus (K070494). The IPL technology is also similar to the Photonova - Photonova Family of pulsed light systems (K073477), in fact the intended use and the emission parameter are very similar to E-fight line. The LED technology is equivalent to the p… | 2008 |
| * | K031425 | Gentlewaves Led Photomodulation DeviceSummary page 3…light systems (K073477), in fact the intended use and the emission parameter are very similar to E-fight line. The LED technology is equivalent to the predicate devices K03 1425 - Light Bioscience LLC- Gentlewaves Led Photomodulation, K042630 - Skincare Technology Inc. - RevLight, K030426 - Photo Therapeut… | 2004 |
| * | K042630 | Revlight Skin Care SystemSummary page 3…n parameter are very similar to E-fight line. The LED technology is equivalent to the predicate devices K03 1425 - Light Bioscience LLC- Gentlewaves Led Photomodulation, K042630 - Skincare Technology Inc. - RevLight, K030426 - Photo Therapeutics Limited - Ominilux Revive, K030883 - Photo Therapeutics Limit… | 2005 |
| * | K030426 | Omnilux RedSummary page 2…nlg LImiedOmniu Revive K034263 Photo Therapeutics Limited Omninilux Bluie K030426 Quantel Derma Gmbh LEDA K090762 PhotoActif LLC… | 2003 |
| * | K030883 | Omnilux BlueSummary page 3…K03 1425 - Light Bioscience LLC- Gentlewaves Led Photomodulation, K042630 - Skincare Technology Inc. - RevLight, K030426 - Photo Therapeutics Limited - Ominilux Revive, K030883 - Photo Therapeutics Limited - Ominilux Blue, K090762 - Quantel Derma Gmbh - LEDA, K(060792 - PhotoActif LLC - IllumiMed. The out… | 2003 |
| * | K090762 | LEDASummary page 2…cs Limited Omninilux Bluie K030426 Quantel Derma Gmbh LEDA K090762 PhotoActif LLC IllumniMed K060792 LPG One Inc.… | 2009 |
| * | K060792 | IllumimedSummary page 2…mbh LEDA K090762 PhotoActif LLC IllumniMed K060792 LPG One Inc. CELLU M6 Keymodule K053225 4. Device Description The… | 2006 |
| * | K053225 | Cellu M6 Keymodule ISummary page 2…IllumniMed K060792 LPG One Inc. CELLU M6 Keymodule K053225 4. Device Description The E-light Line is a family of devices with three types of output emitted from different handpieces… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124064 | Young Again | 2013 | 1 |
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 15 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 10 of the 250 ancestors have a recall of any class.
- Of its descendants, K124064 (Espansione Marketing S.P.A, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 F-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following: IPL Technology is intended for: • Treatment of Acne (from 390 to 1200nm filter) * Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae , and facial and leg veins (from 550 tol200nm filter). * Removal of unwanted hair in all skin types (from 570- to 1200nm filter) LED Technology is…
Read the full statement (130 words)
The F-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following:
IPL Technology is intended for:
• Treatment of Acne (from 390 to 1200nm filter)
* Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts,
scars, striae , and facial and leg veins (from 550 tol200nm filter).
* Removal of unwanted hair in all skin types (from 570- to 1200nm filter)
LED Technology is intended:
* Yellow LED 594 nm - for treatment of periorbital wrinkles and rhytides
* Blue LED 428nm - to treat dermatological conditions and specifically indicated to treat
moderate inflammatory acne vulgaris
* Red LED 632nm - for treatment of superficial, benign vascular and pigmented lesions
VACUUM Technology is intended to:
*Improve Lymphatic circulation in the treated area
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092734: E-Light Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092734
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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