510(k) · Cleared
ClearedPalomar Q-Yag 5 ND:Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 6, 2006 after a 196-day review. The FDA summary names its predicate without a number. 120 later devices descend from it.
- Decided
- Dec 6, 2006
- Review
- 196 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
120 later devices descend from it, 5 citing it directly.
- This deviceK061436 Palomar Q-Yag 5 ND:Yag Laser SystemPalomar Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
- Descendant · cites it directly · 57 of its ownK133254 Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014
- Descendant · 2 generations on · 49 of its ownK143105 Picosure WorkstationCynosure, Inc. · 2015
- Descendant · 3 generations on · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · cites it directly · 35 of its ownK110370 Q-ClearLight Age, Inc. · 2011
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K113588Spectra Laser SystemLutronic Corporation · 2012 · cites it directly82descendants
- K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014 · cites it directly57descendants
- K143105Picosure WorkstationCynosure, Inc. · 2015 · 2 generations on49descendants
- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · 3 generations on41descendants
- K110370Q-ClearLight Age, Inc. · 2011 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061436 | Palomar Q-Yag 5 ND:Yag Laser System | Palomar Medical Technologies, Inc. | 2006 | — |
| +1 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| +1 | K133254 | Revlite Q-Switched ND:Yag Laser System | Cynosure, Inc. | 2014 | — |
| +2 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| +3 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +1 | K110370 | Q-Clear | Light Age, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 14 | 0 |
| 2025 | 20 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | — | Continuum Electro-Optics, Inc. Medlite C3 Q-Switched Nd:YAG Laser Named without a submission number | |
| * | — | Palomar Q-YAG 5 Nd:YAG Laser System Named without a submission number |
What descends from it? (120)
See all 1205 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?
- Of its descendants, K113588 (Lutronic Corporation, 2012) has gone furthest, with 82 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 Palomar Q-YAG 5TM Nd:YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation, dark ink tattoo removal (e.g., black ink), removal of pigmented lesions, including, but not limited to, lentigines, nevi, melasma, and caf6-au-lait, and the removal or lightening of hair. The 532 nm wavelength is indicated for the removal of red ink tattoos, treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, portwine stains, and most pigmented lesions (e.g., lentigines, ephlides).
The 1064/532 nm blended wavelength is indicated for tattoo removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061436: Palomar Q-Yag 5 ND:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061436
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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