510(k) · Cleared
ClearedElite + Laser System
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 Sep 11, 2014 as substantially equivalent to K034030 (Cynosure, Inc., 2004) after a 104-day review. Its family tree reaches back 1 generation to 2004. 44 later devices descend from it.
- Decided
- Sep 11, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K034030 (2004). 44 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK034030 Apogee EliteCynosure, Inc. · 2004
- This deviceK141425 Elite + Laser SystemCynosure, Inc. · 2014
- Descendant · cites it directly · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
- Descendant · 2 generations on · 36 of its ownK160368 EVO platformQuanta System Spa · 2016
- Descendant · 3 generations on · 30 of its ownK163222 Discovery Pico FamilyQuanta System Spa · 2016
- Descendant · 4 generations on · 21 of its ownK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- Descendant · 5 generations on · 20 of its ownK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K152012EVO platformQuanta System Spa · 2015 · cites it directly37descendants
- K160368EVO platformQuanta System Spa · 2016 · 2 generations on36descendants
- K163222Discovery Pico FamilyQuanta System Spa · 2016 · 3 generations on30descendants
- K171945Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017 · 4 generations on21descendants
- K172376Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K034030 | Apogee Elite | Cynosure, Inc. | 2004 | — |
| 0 (this device) | K141425 | Elite + Laser System | Cynosure, Inc. | 2014 | — |
| +1 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| +2 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| +3 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| +4 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| +5 | K172376 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K034030 | Apogee EliteSummary page 4…0 Product Code(s) GEX 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed Apogee Elite K034030 807.92(2)(4) Device Description Cynosure Elite+ laser has an Alexandrite crystal rod as th… | 2004 |
What descends from it? (44)
See all 445 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. 2014, 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?
755 nm: The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064 nm…
Read the full statement (233 words)
755 nm:
The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm:
The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis 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 indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141425: Elite + Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141425
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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