510(k) · Cleared
ClearedDermacool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optomed Corp. · GEX Powered Laser Surgical Instrument
Cleared on Apr 14, 1999 as substantially equivalent to K974381 (Candela Corp., 1998) and 1 other predicate after a 63-day review. Its family tree reaches back 3 generations to 1996. 1,062 later devices descend from it.
- Decided
- Apr 14, 1999
- Review
- 63 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963094 (1996). 4 ancestors in all, the oldest K951033 (1996). 1,062 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 2 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 1 generation backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- This deviceK990417 DermacoolOptomed Corp. · 1999
- Descendant · cites it directly · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- Descendant · 2 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
- Descendant · 2 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled
- Descendant · 2 generations on · 756 of its ownK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- Descendant · 3 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
Showing 5 of 1,062 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,062 · See all- K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · cites it directly1,046descendants
- K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 2 generations on856descendants
- K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 2 generations on756descendants
- K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd. · 2003 · 2 generations on756descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 3 generations on737descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −2 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −1 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| 0 (this device) | K990417 | Dermacool | Optomed Corp. | 1999 | — |
| +1 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| +2 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
| +2 | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems | Lumenis, Ltd. | 2003 | 1 |
| +2 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| +3 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 16 | 0 |
| 2006 | 23 | 0 |
| 2007 | 25 | 0 |
| 2008 | 40 | 0 |
| 2009 | 27 | 0 |
| 2010 | 27 | 0 |
| 2011 | 26 | 0 |
| 2012 | 22 | 0 |
| 2013 | 35 | 0 |
| 2014 | 37 | 0 |
| 2015 | 41 | 0 |
| 2016 | 49 | 0 |
| 2017 | 53 | 0 |
| 2018 | 45 | 0 |
| 2019 | 37 | 0 |
| 2020 | 53 | 0 |
| 2021 | 49 | 0 |
| 2022 | 78 | 0 |
| 2023 | 65 | 0 |
| 2024 | 93 | 0 |
| 2025 | 127 | 0 |
| 2026 | 75 | 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 |
|---|---|---|---|
| * | K974381 | Candela Gentlelase GL Dermatological LaserSummary page 1…prior, during and after laser or light treatment. X. Substantial Equivalence: The DermaCoolTM is substanially equilvalent to laser accessories cleared by Candela under K974381 as a laser accessory, and under K951033 as a pack, hot or cold. It is also equivalent to Cool Laser Optics, Inc. CLO Cool Wand, C… | 1998 |
| * | K951033 | Andela Dynamic Cooling DeviceSummary page 1…treatment. X. Substantial Equivalence: The DermaCoolTM is substanially equilvalent to laser accessories cleared by Candela under K974381 as a laser accessory, and under K951033 as a pack, hot or cold. It is also equivalent to Cool Laser Optics, Inc. CLO Cool Wand, Cool Bag, and CLO Recirculating Slim Pack… | 1996 |
What descends from it? (1,062)
See all 1,0623 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K020839 (Lumenis, Inc., 2002) has gone furthest, with 1,046 descendants of its own.
- 4 other devices also cite its predicate K974381.
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?
DermaCool is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for:
1. The reduction of pain,
2. Less discomfort,
3. Cooling of the skin prior, during and after laser or light 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/K990417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990417: Dermacool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990417
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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