510(k) · Cleared
ClearedCynergy Multiplex 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 Jun 27, 2005 after a 91-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 27, 2005
- Review
- 91 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK050779 Cynergy Multiplex LaserCynosure, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK180593 Vbeam Prima Laser SystemSyneron-Candela · 2018
- Descendant · 2 generations on · 1 of its ownK183452 Vbeam Prima Laser SystemCandela Corp. · 2019
- Descendant · 3 generations on · 0 of its ownK230990 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam…Candela Corporation · 2023
Most influential descendants
Showing 3 of 3 · See all- K180593Vbeam Prima Laser SystemSyneron-Candela · 2018 · cites it directly2descendants
- K183452Vbeam Prima Laser SystemCandela Corp. · 2019 · 2 generations on1descendant
- K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050779 | Cynergy Multiplex Laser | Cynosure, Inc. | 2005 | — |
| +1 | K180593 | Vbeam Prima Laser System | Syneron-Candela | 2018 | — |
| +2 | K183452 | Vbeam Prima Laser System | Candela Corp. | 2019 | — |
| +3 | K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | Candela Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (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 Cynergy laser Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180593 | Vbeam Prima Laser System | 2018 | 2 |
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, K180593 (Syneron-Candela, 2018) has gone furthest, with 2 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 (176 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 barbae (PFB).
585 - 600nm with 1,064nm Wavelength Multiplex Mode: The wavelength multiplex
mode is intended for benign vascular and vascular dependant lesions removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050779: Cynergy Multiplex Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050779
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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