510(k) · Cleared
ClearedPalomar SLP 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Products, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 6, 2001 after an 87-day review. The FDA summary names its predicate without a number. 906 later devices descend from it.
- Decided
- Dec 6, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
906 later devices descend from it, 6 citing it directly.
- This deviceK013028 Palomar SLP 1000Palomar Medical Products, Inc. · 2001
- Descendant · cites it directly · 681 of its ownK024064 Polaris DSSyneron Medical, Ltd. · 2003
- Descendant · cites it directly · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 3 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · 2 generations on · 456 of its ownK052324 Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005
Showing 5 of 906 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 906 · See all- K024064Polaris DSSyneron Medical, Ltd. · 2003 · cites it directly681descendants
- K030186Polris LVSyneron Medical, Ltd. · 2003 · cites it directly680descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 2 generations on678descendants
- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 3 generations on476descendants
- K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005 · 2 generations on456descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013028 | Palomar SLP 1000 | Palomar Medical Products, Inc. | 2001 | — |
| +1 | K024064 | Polaris DS | Syneron Medical, Ltd. | 2003 | — |
| +1 | K030186 | Polris LV | Syneron Medical, Ltd. | 2003 | — |
| +2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +2 | K052324 | Polaris LV, Lva Applicator | Syneron Medical, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 19 | 0 |
| 2009 | 18 | 0 |
| 2010 | 21 | 0 |
| 2011 | 16 | 0 |
| 2012 | 20 | 0 |
| 2013 | 27 | 0 |
| 2014 | 39 | 0 |
| 2015 | 30 | 0 |
| 2016 | 45 | 0 |
| 2017 | 41 | 0 |
| 2018 | 45 | 0 |
| 2019 | 31 | 0 |
| 2020 | 45 | 0 |
| 2021 | 54 | 0 |
| 2022 | 77 | 0 |
| 2023 | 78 | 0 |
| 2024 | 101 | 0 |
| 2025 | 114 | 0 |
| 2026 | 65 | 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 |
|---|---|---|---|
| * | — | LightSheer Diode Array Laser Named without a submission number | |
| * | — | Laserscope Lyra G Surgical Laser System Named without a submission number |
What descends from it? (906)
See all 9066 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, K024064 (Syneron Medical, Ltd., 2003) has gone furthest, with 681 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 Super Long Pulse, SLP™ 1000, diode laser system is
indicated for the treatment of pseudofolliculitis barbae in Skin
Types I-VI.
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/K013028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013028: Palomar SLP 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013028
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026