510(k) · Cleared
ClearedUltralight 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 Dec 14, 2004 as substantially equivalent to K003460 (Palomar Medical Technologies, Inc., 2001) and 3 other predicates after a 238-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 14, 2004
- Review
- 238 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K950019 (1995). 7 ancestors in all, the oldest K942622 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 2 generations backK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
- 1 generation backK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
- This deviceK041011 Ultralight II ND:Yag Laser SystemSandstone Medical Technologies, LLC · 2004
- Descendant · cites it directly · 3 of its ownK082407 Modification to Ultralight II ND: Yag Laser SystemSandstone Medical Technologies, LLC · 2009
- Descendant · 2 generations on · 2 of its ownK110502 Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 3 generations on · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
- Descendant · 4 generations on · 0 of its ownK233143 PiXel8-RevealRohrer Aesthetics · 2024
- Descendant · cites it directly · 0 of its ownK083272 Skinclear Q-Switched ND:Yag LaserGlobal USA Distribution, LLC · 2008
Most influential descendants
Showing 5 of 5 · See all- K082407Modification to Ultralight II ND: Yag Laser SystemSandstone Medical Technologies, LLC · 2009 · cites it directly3descendants
- K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K123777Multilaser SystemUltralight Laser Technologies, LLC · 2013 · 3 generations on1descendant
- K233143PiXel8-RevealRohrer Aesthetics · 2024 · 4 generations on0descendants
- K083272Skinclear Q-Switched ND:Yag LaserGlobal USA Distribution, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −2 | K973719 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
| −1 | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser | Continuum Biomedical, Inc. | 1999 | — |
| 0 (this device) | K041011 | Ultralight II ND:Yag Laser System | Sandstone Medical Technologies, LLC | 2004 | — |
| +1 | K082407 | Modification to Ultralight II ND: Yag Laser System | Sandstone Medical Technologies, LLC | 2009 | — |
| +2 | K110502 | Triplex ER. Yag / ND: Yag System | Sandstone Medical Technologies, LLC | 2011 | — |
| +3 | K123777 | Multilaser System | Ultralight Laser Technologies, LLC | 2013 | — |
| +4 | K233143 | PiXel8-Reveal | Rohrer Aesthetics | 2024 | — |
| +1 | K083272 | Skinclear Q-Switched ND:Yag Laser | Global USA Distribution, LLC | 2008 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K003460 | Palomar Clear Light ND: Yag Laser SystemSummary page 1…rument, Surgical, Powered, laser 79-GEX, 21 CFR 87848 Legally Marketed Predicate Device: Clear Light T Nd:Yag Laser K003460 Medlite Laser System K970808, K983054 and K01 1677. Description of the UltraLight I… | 2001 |
| * | K970808 | Medlite IV Q-Switched, Frequency Doubled, ND:Yag LaserSummary page 1…79-GEX, 21 CFR 87848 Legally Marketed Predicate Device: Clear Light T Nd:Yag Laser K003460 Medlite Laser System K970808, K983054 and K01 1677. Description of the UltraLight I1 Nd:YAG The UltraLight HINd:YAG Laser System consists of a power Las… | 1997 |
| * | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserSummary page 1…X, 21 CFR 87848 Legally Marketed Predicate Device: Clear Light T Nd:Yag Laser K003460 Medlite Laser System K970808, K983054 and K01 1677. Description of the UltraLight I1 Nd:YAG The UltraLight HINd:YAG Laser System consists of a power Laser System… | 1999 |
| * | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag LaserSummary page 1…848 Legally Marketed Predicate Device: Clear Light T Nd:Yag Laser K003460 Medlite Laser System K970808, K983054 and K01 1677. Description of the UltraLight I1 Nd:YAG The UltraLight HINd:YAG Laser System consists of a power Laser System:… | 2001 |
What descends from it? (5)
2 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 9 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K082407 (Sandstone Medical Technologies, LLC, 2009) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K003460.
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?
At the 1064 nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
At the 532 nm 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. lentigines, ephildes)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041011: Ultralight II ND:Yag 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/K041011
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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