510(k) · Cleared
ClearedZENO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyrell, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 1, 2005 as substantially equivalent to K982082 (National Biological Corp., 1998) and 2 other predicates after a 175-day review. Its family tree reaches back 1 generation to 1998. 142 later devices descend from it.
- Decided
- Jun 1, 2005
- Review
- 175 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K982082 (1998). 3 ancestors in all. 142 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK982082 Handisol Wound HealingNational Biological Corp. · 1998
- This deviceK043377 ZENOTyrell, Inc. · 2005
- Descendant · cites it directly · 137 of its ownK080591 Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008
- Descendant · cites it directly · 132 of its ownK060653 ThermaclearDermacare, Inc. · 2006
- Descendant · 2 generations on · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · 2 generations on · 81 of its ownK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- Descendant · 2 generations on · 76 of its ownK124042 Tanda Mini Skincare SystemSyneron Beauty · 2013
Showing 5 of 142 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 142 · See all- K080591Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008 · cites it directly137descendants
- K060653ThermaclearDermacare, Inc. · 2006 · cites it directly132descendants
- K121435Silkn BlueHome Skinovations, Ltd. · 2013 · 2 generations on125descendants
- K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · 2 generations on81descendants
- K124042Tanda Mini Skincare SystemSyneron Beauty · 2013 · 2 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982082 | Handisol Wound Healing | National Biological Corp. | 1998 | — |
| 0 (this device) | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
| +1 | K080591 | Tanda Skincare System, Model: Ptscs | Pharos Life Corporation | 2008 | — |
| +1 | K060653 | Thermaclear | Dermacare, Inc. | 2006 | — |
| +2 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +2 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| +2 | K124042 | Tanda Mini Skincare System | Syneron Beauty | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 0 |
| 2025 | 41 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K982082 | Handisol Wound HealingSummary page 4…Class II Predicate Devices: National Biological Corporation Donna-Wand K(982082 CureLight Ltd. ClearLight Phototherapy System, Model CI 420… | 1998 |
| * | K013623 | Clearlight Phototheraphy System, Model CL 420Summary page 4…2082 CureLight Ltd. ClearLight Phototherapy System, Model CI 420 K(013623 Radiancy (Israel) Ltd. Radiancy Acne System With ClearTouch L… | 2002 |
| * | K032205 | Radiancy Acne System with Cleartouch Light Unit AssemblySummary page 4…Radiancy (Israel) Ltd. Radiancy Acne System With ClearTouch Light Unit A K(032205 Description of the Device Zeno is a portable hand-held device that produces accurately controlled low level sustained heat for us… | 2003 |
What descends from it? (142)
See all 1427 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?
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?
Zeno is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
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/K043377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043377: ZENO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043377
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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