510(k) · Cleared
ClearedHelios II Q-Switched ND:Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laseroptek Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 28, 2009 as substantially equivalent to K053139 (Fotona D.D., 2006) and 2 other predicates after a 180-day review. Its family tree reaches back 3 generations to 1998. 6 later devices descend from it.
- Decided
- Apr 28, 2009
- Review
- 180 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K971207 (1998). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971207 Softlight Q-Switched (ND:Yag) LaserThermolase Corp. · 1998
- 2 generations backK023967 Palomar Q-Yag ND:Yag Laser SystemPalomar Medical Technologies, Inc. · 2003
- 1 generation backK053139 Fotona QX ND:Yag/KTP Laser SystemFotona D.D. · 2006
- This deviceK083203 Helios II Q-Switched ND:Yag Laser SystemLaseroptek Co., Ltd. · 2009
- Descendant · cites it directly · 5 of its ownK152856 Helios IIILaseroptek Co., Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK212663 Helios IV 785Laseroptek Co., Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK230373 HELIOS 785 PicoLaseroptek Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK243780 HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242206 ActivoDaeju Meditech Engineering Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152856Helios IIILaseroptek Co., Ltd. · 2016 · cites it directly5descendants
- K212663Helios IV 785Laseroptek Co., Ltd. · 2022 · 2 generations on3descendants
- K230373HELIOS 785 PicoLaseroptek Co., Ltd. · 2023 · 3 generations on2descendants
- K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025 · 4 generations on0descendants
- K242206ActivoDaeju Meditech Engineering Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971207 | Softlight Q-Switched (ND:Yag) Laser | Thermolase Corp. | 1998 | — |
| −2 | K023967 | Palomar Q-Yag ND:Yag Laser System | Palomar Medical Technologies, Inc. | 2003 | — |
| −1 | K053139 | Fotona QX ND:Yag/KTP Laser System | Fotona D.D. | 2006 | — |
| 0 (this device) | K083203 | Helios II Q-Switched ND:Yag Laser System | Laseroptek Co., Ltd. | 2009 | — |
| +1 | K152856 | Helios III | Laseroptek Co., Ltd. | 2016 | — |
| +2 | K212663 | Helios IV 785 | Laseroptek Co., Ltd. | 2022 | — |
| +3 | K230373 | HELIOS 785 Pico | Laseroptek Co., Ltd. | 2023 | — |
| +4 | K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025 | — |
| +2 | K242206 | Activo | Daeju Meditech Engineering Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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? (3)
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 |
|---|---|---|---|
| * | K053139 | Fotona QX ND:Yag/KTP Laser SystemSummary page 2…elios IL® Q-Switched Nd:YAG Laser System Legally Marketed Predicate Devices: Fotona QX Nd: VA G/KTP Laser Systemt, K053 139, by Fotona d.d. Medlite C3 Q Switched Nd: YA G Laser,… | 2006 |
| * | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser | 2001 |
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152856 | Helios III | 2016 | 5 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K152856 (Laseroptek Co., Ltd., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K053139.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Incision, excision, ablation, vaporization of soft tissue for general dermatology.
Removal or lightening of unwanted hair with or without adjuvant preparation.
Tattoo Removal
* dark ink: blue and black
* light ink: red
* light ink: sky blue
* light ink: green
Treatment of Vascular Lesions:
* port wine birthmarks
* telangiectasias
* spider angioma
* cherry angioma
* spider nevi
Treatment of Pigmented Lesions:
* cafAau-lait birthmarks
* solar lentiginos
* senile lentiginos
* backer's nevi
* freckles
* nevus spilus
* nevus of ota
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083203: Helios II Q-Switched ND:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083203
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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