510(k) · Cleared
ClearedCoolskin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elbio Co., Ltd. · ILO Pack, Hot Or Cold, Water Circulating
Cleared on Jun 10, 2009 as substantially equivalent to K060395 (Zimmer Elektromedizin GmbH, 2006) after a 245-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 10, 2009
- Review
- 245 days
- Class
- Class II
- Product code
- ILO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963094 (1996). 37 ancestors in all, the oldest K904627 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 7 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 6 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 5 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 4 generations backK990119 Epi-Star Surgical Laser SysterNidek, Inc. · 2000
- 3 generations backK013864 Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc. · 2002
- 2 generations backK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
- 1 generation backK060395 Cryo, Model V6.0Zimmer Elektromedizin GmbH · 2006
- This deviceK083008 CoolskinElbio Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −7 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −6 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −5 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −4 | K990119 | Epi-Star Surgical Laser Syster | Nidek, Inc. | 2000 | — |
| −3 | K013864 | Modification to Epi-Star Surgical Laser System, M0DEL DS-60 | Nidek, Inc. | 2002 | — |
| −2 | K040727 | CRYO 5 | Zimmer Elektromedizin GmbH | 2004 | — |
| −1 | K060395 | Cryo, Model V6.0 | Zimmer Elektromedizin GmbH | 2006 | — |
| 0 (this device) | K083008 | Coolskin | Elbio Co., Ltd. | 2009 | — |
| +1 | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
| +2 | K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 1 | 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 ILO? 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 ILO device
- #1 K213097 Armory Motionscore 4.7 · 5 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K060395 | Cryo, Model V6.0Summary page 1…r usual name: Skin cooling device 14-Device Classification Name: pack, cold, water circulating 15-Substantial Equivalency is claimed against Cryo V6.0, cleared under K060395 16-Description of the Device: COOLSKIN is a 14" by 16" by 2 % ft, 66 lb thermo-cooling mobile device that applies cont… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213294 | Dermal Cooling System | 2022 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 37 ancestors has a recall of any class.
- Of its descendants, K213294 (R2 Technologies, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K060395.
How does its category compare?
All ILO devicesILO Pack, Hot Or Cold, Water Circulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ILO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · ILO
Too few ILO 510(k)s in any year since 2007 to give a median.
Recalls per year · ILO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILO
9in 2025
MAUDE reports naming product code ILO, 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 | 2 | — | 0 | 14 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 2 | 17 |
| 2010 | 0 | — | 0 | 171 |
| 2011 | 0 | — | 1 | 241 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 0 | — | 8 | 60 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 0 | — | 0 | 60 |
| 2016 | 0 | — | 0 | 44 |
| 2017 | 0 | — | 1 | 43 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 14 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083008: Coolskin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083008
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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