510(k) · Cleared
ClearedTriplex ER. Yag / ND: Yag 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 Apr 27, 2011 as substantially equivalent to K032599 (Medical Laser Technologies, LLC, 2003) and 1 other predicate after a 64-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 27, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954013 (1996). 16 ancestors in all, the oldest K942622 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 4 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- 3 generations backK980361 Dermablate ER: Yag Laser SystemAesculap-Meditec North America · 1998
- 2 generations backK014057 Dermastar ER:Yag Laser SystemAsclepion-Meditec AG · 2002
- 1 generation backK032599 Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 2003
- This deviceK110502 Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011
- Descendant · cites it directly · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK233143 PiXel8-RevealRohrer Aesthetics · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −4 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −3 | K980361 | Dermablate ER: Yag Laser System | Aesculap-Meditec North America | 1998 | — |
| −2 | K014057 | Dermastar ER:Yag Laser System | Asclepion-Meditec AG | 2002 | — |
| −1 | K032599 | Medical Laser Technologies, LLC MTL Erbium:Yag Laser System | Medical Laser Technologies, LLC | 2003 | — |
| 0 (this device) | K110502 | Triplex ER. Yag / ND: Yag System | Sandstone Medical Technologies, LLC | 2011 | — |
| +1 | K123777 | Multilaser System | Ultralight Laser Technologies, LLC | 2013 | — |
| +2 | K233143 | PiXel8-Reveal | Rohrer Aesthetics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K032599 | Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemSummary page 1…Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 Legally Marketed Predicate MLT Erbium:YAG Laser System (K)032599 Device: Ultralight 11Nd:YAG Laser System (K)082407 Description of the Triplex The Apex system… | 2003 |
| * | K082407 | Modification to Ultralight II ND: Yag Laser SystemSummary page 1…79-GEX, 21 CFR 878-48 Legally Marketed Predicate MLT Erbium:YAG Laser System (K)032599 Device: Ultralight 11Nd:YAG Laser System (K)082407 Description of the Triplex The Apex system and controls are contained in a single Er:YAG INd:YAG Laser System: con… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123777 | Multilaser System | 2013 | 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?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K123777 (Ultralight Laser Technologies, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K032599.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery). The Nd:YAG handpiece is indicated for: * At the 1064nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or…
Read the full statement (102 words)
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Nd:YAG handpiece is indicated for:
* At the 1064nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
* At the 532nm 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 (eg: lentigies, ephildes)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110502: Triplex ER. Yag / ND: Yag System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110502
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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