510(k) · Cleared
ClearedModification to Ultralight II ND: Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandstone Medical Technologies, LLC · GEX Powered Laser Surgical Instrument
Cleared on Feb 3, 2009 as substantially equivalent to K041011 (Sandstone Medical Technologies, LLC, 2004) after a 166-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 3, 2009
- Review
- 166 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950019 (1995). 8 ancestors in all, the oldest K942622 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 3 generations backK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
- 2 generations backK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
- 1 generation backK041011 Ultralight II ND:Yag Laser SystemSandstone Medical Technologies, LLC · 2004
- This deviceK082407 Modification to Ultralight II ND: Yag Laser SystemSandstone Medical Technologies, LLC · 2009
- Descendant · cites it directly · 2 of its ownK110502 Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK233143 PiXel8-RevealRohrer Aesthetics · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −3 | K973719 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
| −2 | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser | Continuum Biomedical, Inc. | 1999 | — |
| −1 | K041011 | Ultralight II ND:Yag Laser System | Sandstone Medical Technologies, LLC | 2004 | — |
| 0 (this device) | K082407 | Modification to Ultralight II ND: Yag Laser System | Sandstone Medical Technologies, LLC | 2009 | — |
| +1 | K110502 | Triplex ER. Yag / ND: Yag System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K123777 | Multilaser System | Ultralight Laser Technologies, LLC | 2013 | — |
| +3 | K233143 | PiXel8-Reveal | Rohrer Aesthetics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K041011 | Ultralight II ND:Yag Laser SystemSummary page 1…79-GEX, 21 CFR 878-48 Legally Marketed Predicate Device: UltraLight II Nd:YAG Laser System K041011 Description of the UltraLight H Nd:YAG The UltraLight II Nd:YAG Laser System consists of a power Laser System:… | 2004 |
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 |
|---|---|---|---|
| K110502 | Triplex ER. Yag / ND: Yag System | 2011 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K110502 (Sandstone Medical Technologies, LLC, 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K041011.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
At the 1064 unm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
At the 532 unm wavelength - removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ep~hildes)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082407: Modification to Ultralight II ND: Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082407
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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