510(k) · Cleared
ClearedEpi-Star Surgical Laser Syster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 27, 2000 as substantially equivalent to K981447 (Nidek, Inc., 1998) and 3 other predicates after a 561-day review. Its family tree reaches back 4 generations to 1996. 50 later devices descend from it.
- Decided
- Jul 27, 2000
- Review
- 561 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K963094 (1996). 8 ancestors in all. 50 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 3 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 2 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 1 generation backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- This deviceK990119 Epi-Star Surgical Laser SysterNidek, Inc. · 2000
- Descendant · cites it directly · 49 of its ownK013864 Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc. · 2002
- Descendant · 2 generations on · 48 of its ownK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
- Descendant · 3 generations on · 36 of its ownK060407 Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006
- Descendant · 4 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · 4 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K013864Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc. · 2002 · cites it directly49descendants
- K040727CRYO 5Zimmer Elektromedizin GmbH · 2004 · 2 generations on48descendants
- K060407Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006 · 3 generations on36descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 4 generations on35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −3 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −2 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −1 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| 0 (this device) | K990119 | Epi-Star Surgical Laser Syster | Nidek, Inc. | 2000 | — |
| +1 | K013864 | Modification to Epi-Star Surgical Laser System, M0DEL DS-60 | Nidek, Inc. | 2002 | — |
| +2 | K040727 | CRYO 5 | Zimmer Elektromedizin GmbH | 2004 | — |
| +3 | K060407 | Juniper Cooling Device | Juniper Medical Technology, Inc. | 2006 | — |
| +4 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +4 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981447 | Dio-Light 60 Laser SystemSummary page 1…CO2 Laser System is substantially equivalent to the following currently marketed devices: Manufacturer Product Model 510(k) Number Decision Date Nidek Inc. DioLight 60 K981447 5 June 1998 Coherent/Palomar LightSheer K98420 4 May 1998 Sharplan Lasers EpiTouch ALEX K973354 4 December 1997 Candela Corp. Gen… | 1998 |
| Kept off the family tree | K984208 | FDA’s K984208 is Silverlon Island Dressing, Silverlon Island Pad Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1999 |
| * | K973354 | Sharplan Epitouch Alexandrite Laser System (5000)Summary page 1…facturer Product Model 510(k) Number Decision Date Nidek Inc. DioLight 60 K981447 5 June 1998 Coherent/Palomar LightSheer K98420 4 May 1998 Sharplan Lasers EpiTouch ALEX K973354 4 December 1997 Candela Corp. GentleLASE K981351 13 July 1998 Cynosure Inc. Photogencia LPIR K971737 8 August 1997 Page 1 of 4… | 1997 |
| * | K981351 | Candela Gentlelase GL Dermatological LaserSummary page 1…e Nidek Inc. DioLight 60 K981447 5 June 1998 Coherent/Palomar LightSheer K98420 4 May 1998 Sharplan Lasers EpiTouch ALEX K973354 4 December 1997 Candela Corp. GentleLASE K981351 13 July 1998 Cynosure Inc. Photogencia LPIR K971737 8 August 1997 Page 1 of 4 IV VI Product Description The N… | 1998 |
| * | K971737 | Cynosure Photogenica Lpir Dermatological LaserSummary page 1…t/Palomar LightSheer K98420 4 May 1998 Sharplan Lasers EpiTouch ALEX K973354 4 December 1997 Candela Corp. GentleLASE K981351 13 July 1998 Cynosure Inc. Photogencia LPIR K971737 8 August 1997 Page 1 of 4 IV VI Product Description The Nidek Epi-Star Surgical Laser System consists of a mo… | 1997 |
What descends from it? (50)
See all 501 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013864 | Modification to Epi-Star Surgical Laser System, M0DEL DS-60 | 2002 | 49 |
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 4 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K013864 (Nidek, Inc., 2002) has gone furthest, with 49 descendants of its own.
- 2 other devices also cite its predicate K981447.
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?
The Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions in dermatology, and for the removal of hair.
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/K990119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990119: Epi-Star Surgical Laser Syster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990119
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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