510(k) · Cleared
ClearedApogee Elite
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 Feb 9, 2004 after a 42-day review. The FDA summary names its predicate without a number. 252 later devices descend from it.
- Decided
- Feb 9, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
252 later devices descend from it, 14 citing it directly.
- This deviceK034030 Apogee EliteCynosure, Inc. · 2004
- Descendant · cites it directly · 179 of its ownK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- Descendant · cites it directly · 113 of its ownK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
- Descendant · cites it directly · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · cites it directly · 112 of its ownK081324 Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Showing 5 of 252 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 252 · See all- K063074Candela 3630 Laser SystemCandela Corp. · 2006 · cites it directly179descendants
- K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008 · cites it directly113descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · cites it directly112descendants
- K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008 · cites it directly112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K034030 | Apogee Elite | Cynosure, Inc. | 2004 | — |
| +1 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| +1 | K073534 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | Candela Corp. | 2008 | — |
| +1 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +1 | K081324 | Candela Family of Q-Switched Alexandrite Lasers | Candela Corp. | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 11 | 0 |
| 2020 | 20 | 0 |
| 2021 | 16 | 0 |
| 2022 | 29 | 0 |
| 2023 | 18 | 0 |
| 2024 | 29 | 0 |
| 2025 | 31 | 0 |
| 2026 | 21 | 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? (2)
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 Apogee TKS Named without a submission number | |
| * | — | Cynosure Acclaim Named without a submission number |
What descends from it? (252)
See all 25214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063074 | Candela 3630 Laser System | 2006 | 179 |
| K073534 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | 2008 | 113 |
| K081352 | Profile Multi-Platform System | 2008 | 112 |
| K081324 | Candela Family of Q-Switched Alexandrite Lasers | 2008 | 112 |
| K090571 | Alma Lasers ALEX755 Module | 2009 | 58 |
| K140719 | Picosure Workstation | 2014 | 50 |
| K141425 | Elite + Laser System | 2014 | 44 |
| K090235 | Elite MPX Laser System with XPL Handpiece | 2009 | 38 |
| K132286 | Hyperion Long Pulsed ND: Yag Laser | 2014 | 3 |
| K161503 | ORION | 2016 | 1 |
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, K063074 (Candela Corp., 2006) has gone furthest, with 179 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?
The Cynosure Apogee Elite Dermatological 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 hair regrowth after 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. The Cynosure Apogee Elite Dermatological laser is…
Read the full statement (222 words)
The Cynosure Apogee Elite Dermatological 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 hair regrowth after 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.
The Cynosure Apogee Elite Dermatological laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiornas, warts, telangiectasia, 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), cafr' au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, 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 indicated 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 pseudofolliculitis barbae (PFB).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034030: Apogee Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034030
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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