510(k) · Cleared
ClearedAramis II Dermatological Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · GEX Powered Laser Surgical Instrument
Cleared on May 6, 2003 as substantially equivalent to K012545 (Lumedics, Ltd., 2001) and 4 other predicates after a 180-day review. Its family tree reaches back 2 generations to 1982. 317 later devices descend from it.
- Decided
- May 6, 2003
- Review
- 180 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K820106 (1982). 11 ancestors in all. 317 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK820106 X-Ray Guaze SpongesStan-Pak Ent. · 1982
- 1 generation backK962791 New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc. · 1997
- This deviceK023734 Aramis II Dermatological LaserQuantel Medical · 2003
- Descendant · cites it directly · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- Descendant · 2 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
- Descendant · 3 generations on · 259 of its ownK061652 Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007
- Descendant · 2 generations on · 230 of its ownK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- Descendant · 3 generations on · 226 of its ownK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
Showing 5 of 317 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 317 · See all- K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · cites it directly316descendants
- K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 2 generations on284descendants
- K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007 · 3 generations on259descendants
- K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006 · 2 generations on230descendants
- K062303Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007 · 3 generations on226descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820106 | X-Ray Guaze Sponges | Stan-Pak Ent. | 1982 | — |
| −1 | K962791 | New Star Model 130 6-Watt ND: Yag Laser System | New Star Lasers, Inc. | 1997 | — |
| 0 (this device) | K023734 | Aramis II Dermatological Laser | Quantel Medical | 2003 | — |
| +1 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| +2 | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
| +3 | K061652 | Palomar LUX1540 Handpiece | Palomar Medical Products, Inc. | 2007 | — |
| +2 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| +3 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 17 | 0 |
| 2019 | 10 | 0 |
| 2020 | 24 | 0 |
| 2021 | 17 | 0 |
| 2022 | 32 | 0 |
| 2023 | 22 | 0 |
| 2024 | 39 | 0 |
| 2025 | 37 | 0 |
| 2026 | 24 | 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? (5)
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 |
|---|---|---|---|
| * | K012545 | Aramis Dermatlogic Laser | 2001 |
| * | K002649 | Aramis Dermatological Laser | 2000 |
| * | K962791 | New Star Model 130 6-Watt ND: Yag Laser SystemSummary page 1…Product Code: GEX Panel: 79 Predicate devices: The Aramis laser (also Aramis I) - KO12545 and KO02649 The New Star Model 130 - K962791 The Smoothbeam Laser System - KO13825 The CoolTouch and CoolTouch I - KO03715 Device descr… | 1997 |
| * | K013825 | Candela Smoothbeam Laser System | 2002 |
| * | K003715 | Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch… | 2001 |
What descends from it? (317)
See all 3172 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K040617 (Reliant Technologies, Inc., 2004) has gone furthest, with 316 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 Aramis I1 Dermatological Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis I1 laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), and for the treatment of periorbital and perioral wrinkles.
The Aramis II Dermatological Laser is also labeled: CAUTION: Federal law restricts the sale to or use by licensed professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023734: Aramis II Dermatological Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023734
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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