510(k) · Cleared
ClearedPalomar Aspire Laser Platform
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 Feb 13, 2009 as substantially equivalent to K081416 (Palomar Medical Products, Inc., 2008) and 4 other predicates after a 109-day review. Its family tree reaches back 16 generations to 1995.
- Decided
- Feb 13, 2009
- Review
- 109 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K943450 (1995). 374 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- 2 generations backK080567 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- 1 generation backK081416 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- This deviceK083165 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2009
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
- 3 generations backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- 2 generations backK080567 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- 1 generation backK081416 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- This deviceK083165 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K053616 | Polaris WR, ST Applicator | Syneron Medical, Ltd. | 2006 | — |
| −3 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| −2 | K080567 | Palomar Aspire Laser Platform | Palomar Medical Products, Inc. | 2008 | — |
| −1 | K081416 | Palomar Aspire Laser Platform | Palomar Medical Products, Inc. | 2008 | — |
| 0 (this device) | K083165 | Palomar Aspire Laser Platform | Palomar Medical Products, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 16 | 0 |
| 1996 | 24 | 0 |
| 1997 | 28 | 0 |
| 1998 | 24 | 0 |
| 1999 | 22 | 0 |
| 2000 | 32 | 0 |
| 2001 | 30 | 0 |
| 2002 | 37 | 0 |
| 2003 | 37 | 0 |
| 2004 | 24 | 0 |
| 2005 | 17 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K081416 | Palomar Aspire Laser PlatformSummary page 1…dicate Devices: The Palomar AspireTM Laser Platform Palomar Medical Technologies, Inc. K081416, K080567 Sciton, Inc. Profile Multi-Platform System… | 2008 |
| * | K080567 | Palomar Aspire Laser PlatformSummary page 1…vices: The Palomar AspireTM Laser Platform Palomar Medical Technologies, Inc. K081416, K080567 Sciton, Inc. Profile Multi-Platform System… | 2008 |
| * | K070388 | Profile Multi-Platform SystemSummary page 1…K081416, K080567 Sciton, Inc. Profile Multi-Platform System K070388 Cynosure, Inc. Cynosure SmartLipo Multiwavelength Laser… | 2007 |
| * | K080121 | Cynosure Smartlipo Multiwavlength LaserSummary page 1…K070388 Cynosure, Inc. Cynosure SmartLipo Multiwavelength Laser K080121 Biolitec, Inc. Ceralas D 980 nm Diode Laser System… | 2008 |
| * | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary page 1…K080121 Biolitec, Inc. Ceralas D 980 nm Diode Laser System K081015 System Description: The Palomar AspireTM Laser Platform is a small transportable… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 9 months on median.
- 19 of the 374 ancestors have a recall of any class.
- 1 other device also cites its predicate K081416.
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?
The Palomar Aspire TM Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further indicated for laser assisted lipolysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083165: Palomar Aspire Laser Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083165
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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