510(k) · Cleared
ClearedCoopersurgical Coagulator for Tattoo Removal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Jun 1, 1999 after a 78-day review. The FDA summary names its predicate without a number. 108 later devices descend from it.
- Decided
- Jun 1, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
108 later devices descend from it, 1 citing it directly.
- This deviceK990850 Coopersurgical Coagulator for Tattoo RemovalCooperSurgical, Inc. · 1999
- Descendant · cites it directly · 107 of its ownK060069 Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 64 of its ownK070298 Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007
- Descendant · 3 generations on · 57 of its ownK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- Descendant · 2 generations on · 56 of its ownK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- Descendant · 4 generations on · 41 of its ownK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K060069Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc. · 2006 · cites it directly107descendants
- K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007 · 2 generations on64descendants
- K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011 · 3 generations on57descendants
- K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011 · 2 generations on56descendants
- K130028Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013 · 4 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990850 | Coopersurgical Coagulator for Tattoo Removal | CooperSurgical, Inc. | 1999 | — |
| +1 | K060069 | Palomar Luxir Fractional Handpiece | Palomar Medical Technologies, Inc. | 2006 | — |
| +2 | K070298 | Modification to Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2007 | — |
| +3 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| +2 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| +4 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 16 | 0 |
| 2026 | 7 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | — | Redfield Corporation’s Redfield Infrared Coagulator for tattoo removal Named without a submission number | |
| * | — | CooperSurgical, Inc.’s InfraRed Coagulator for the treatment of genital condylomas… Named without a submission number |
What descends from it? (108)
See all 1081 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060069 | Palomar Luxir Fractional Handpiece | 2006 | 107 |
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, K060069 (Palomar Medical Technologies, Inc., 2006) has gone furthest, with 107 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The CooperSurgical InfraRed Coagulator is indicated for tattoo removal
through coagulative necrosis of tattoo pigmented tissue.
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/K990850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990850: Coopersurgical Coagulator for Tattoo Removal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990850
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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