510(k) · Cleared
ClearedeLyx-PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Sensory Concept SA · GEX Powered Laser Surgical Instrument
Cleared on Jan 24, 2017 as substantially equivalent to K043329 (Photo Therapeutics Limited, 2005) and 2 other predicates after a 105-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jan 24, 2017
- Review
- 105 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K943450 (1995). 92 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- This deviceK162851 eLyx-PROIntelligent Sensory Concept SA · 2017
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- This deviceK162851 eLyx-PROIntelligent Sensory Concept SA · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −1 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| 0 (this device) | K162851 | eLyx-PRO | Intelligent Sensory Concept SA | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K043329 | Omnilux Revive and BlueSummary page 4…gery Regulation number: 878.4810 Classification code & name: GEX – Powered Laser Surgical Instrument 3. Predicates devices Omnilux Revive & Omnilux blue combination (K043329) Omnilux Revive & Omnilux Plus combination (K050216) Omnilux Plus (K043317) 4. Device description Elyx-PRO is a professional… | 2005 |
| * | K050216 | Omnilux Revive and Omnilux PlusSummary page 4…& name: GEX – Powered Laser Surgical Instrument 3. Predicates devices Omnilux Revive & Omnilux blue combination (K043329) Omnilux Revive & Omnilux Plus combination (K050216) Omnilux Plus (K043317) 4. Device description Elyx-PRO is a professional photomodulation device designed for use in health of… | 2005 |
| * | K043317 | Omnilux PlusSummary page 4…Laser Surgical Instrument 3. Predicates devices Omnilux Revive & Omnilux blue combination (K043329) Omnilux Revive & Omnilux Plus combination (K050216) Omnilux Plus (K043317) 4. Device description Elyx-PRO is a professional photomodulation device designed for use in health office. It offers 6 prepr… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 92 ancestors have a recall of any class.
- 2 other devices also cite its predicate K043329.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
eLyx PRO is intended to emit in the blue and red region of the spectrum for use in dermatology for treatment of mild to moderate forms of acne
eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for use in dermatology for treatment of periorbital wrinkles
eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for the temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness
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/K162851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162851: eLyx-PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162851
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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