510(k) · Cleared
ClearedLaserscope Coolspot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laserscope · GEX Powered Laser Surgical Instrument
Cleared on Dec 18, 1998 after a 31-day review. The FDA summary names its predicate without a number. 1,034 later devices descend from it.
- Decided
- Dec 18, 1998
- Review
- 31 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1,034 later devices descend from it, 4 citing it directly.
- This deviceK984110 Laserscope CoolspotLaserscope · 1998
- Descendant · cites it directly · 1,018 of its ownK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 569 of its ownK032460 Profile BBL SystemSciton, Inc · 2003
- Descendant · 2 generations on · 563 of its ownK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- Descendant · 3 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Showing 5 of 1,034 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,034 · See all- K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002 · cites it directly1,018descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
- K032460Profile BBL SystemSciton, Inc · 2003 · 2 generations on569descendants
- K030426Omnilux RedPhoto Therapeutics Limited · 2003 · 2 generations on563descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 3 generations on517descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984110 | Laserscope Coolspot | Laserscope | 1998 | — |
| +1 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| +2 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +2 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| +2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| +3 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 16 | 0 |
| 2006 | 22 | 0 |
| 2007 | 26 | 0 |
| 2008 | 39 | 0 |
| 2009 | 25 | 0 |
| 2010 | 26 | 0 |
| 2011 | 24 | 0 |
| 2012 | 21 | 0 |
| 2013 | 33 | 0 |
| 2014 | 36 | 0 |
| 2015 | 41 | 0 |
| 2016 | 47 | 0 |
| 2017 | 51 | 0 |
| 2018 | 45 | 0 |
| 2019 | 36 | 0 |
| 2020 | 51 | 0 |
| 2021 | 48 | 0 |
| 2022 | 76 | 0 |
| 2023 | 64 | 0 |
| 2024 | 93 | 0 |
| 2025 | 124 | 0 |
| 2026 | 74 | 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 |
|---|---|---|---|
| * | — | Cool Laser Optics device Named without a submission number | |
| * | — | Cold Packs Named without a submission number |
What descends from it? (1,034)
See all 1,0344 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, K020453 (Palomar Medical Technologies, Inc., 2002) has gone furthest, with 1,018 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?
To provide surface cooling effect during cutaneous laser surgery to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to possibly reduce pain associated with laser treatment.
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/K984110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984110: Laserscope Coolspot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984110
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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