510(k) · Cleared
ClearedCynergy Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 12, 2005 after a 30-day review. The FDA summary names its predicate without a number. 267 later devices descend from it.
- Decided
- Jan 12, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
267 later devices descend from it, 1 citing it directly.
- This deviceK043429 Cynergy LaserCynosure, Inc. · 2005
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 87 of its ownK121346 Picosure WorkstationCynosure, Inc. · 2012
Showing 5 of 267 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 267 · See all- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 3 generations on92descendants
- K121346Picosure WorkstationCynosure, Inc. · 2012 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043429 | Cynergy Laser | Cynosure, Inc. | 2005 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| +4 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 15 | 0 |
| 2017 | 17 | 0 |
| 2018 | 16 | 0 |
| 2019 | 11 | 0 |
| 2020 | 21 | 0 |
| 2021 | 17 | 0 |
| 2022 | 26 | 0 |
| 2023 | 18 | 0 |
| 2024 | 32 | 0 |
| 2025 | 30 | 0 |
| 2026 | 23 | 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? (1)
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 |
|---|---|---|---|
| * | — | Cynosure TriStar laser Named without a submission number |
What descends from it? (267)
See all 2671 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
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?
- Of its descendants, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 descendants 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.
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?
585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal. 1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots)…
Read the full statement (154 words)
585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant
lesions removal.
1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign
vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts,
telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte
and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots),
solar lentigos (sun spots), caf6 au lait manules, seborrheic keratoses, nevi, chloasma,
verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black
and/or blue/black tattoos) 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 intended for the removal of unwanted hair, for the stable long
term, or permanent, hair reduction through selective targeting of melanin in hair follicles,
and for the treatment of psuedofolliculitis barbac (PFB).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043429 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043429: Cynergy Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043429
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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