510(k) · Cleared
ClearedHelios III
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 Jun 2, 2016 as substantially equivalent to K133254 (Cynosure, Inc., 2014) and 1 other predicate after a 247-day review. Its family tree reaches back 18 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 2, 2016
- Review
- 247 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 270 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 2 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 1 generation backK133254 Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014
- This deviceK152856 Helios IIILaseroptek Co., Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK212663 Helios IV 785Laseroptek Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK230373 HELIOS 785 PicoLaseroptek Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK243780 HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242206 ActivoDaeju Meditech Engineering Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK240752 Deka ToroEl.En S.P.A. · 2024
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 5 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 4 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 3 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 2 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 1 generation backK133254 Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014
- This deviceK152856 Helios IIILaseroptek Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K212663Helios IV 785Laseroptek Co., Ltd. · 2022 · cites it directly3descendants
- K230373HELIOS 785 PicoLaseroptek Co., Ltd. · 2023 · 2 generations on2descendants
- K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025 · 3 generations on0descendants
- K242206ActivoDaeju Meditech Engineering Co., Ltd. · 2024 · cites it directly0descendants
- K240752Deka ToroEl.En S.P.A. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −5 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −4 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −2 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −1 | K133254 | Revlite Q-Switched ND:Yag Laser System | Cynosure, Inc. | 2014 | — |
| 0 (this device) | K152856 | Helios III | Laseroptek Co., Ltd. | 2016 | — |
| +1 | K212663 | Helios IV 785 | Laseroptek Co., Ltd. | 2022 | — |
| +2 | K230373 | HELIOS 785 Pico | Laseroptek Co., Ltd. | 2023 | — |
| +3 | K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025 | — |
| +1 | K242206 | Activo | Daeju Meditech Engineering Co., Ltd. | 2024 | — |
| +3 | K240752 | Deka Toro | El.En S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 22 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 24 | 0 |
| 2001 | 24 | 0 |
| 2002 | 33 | 0 |
| 2003 | 23 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K133254 | Revlite Q-Switched ND:Yag Laser SystemSummary page 4…(21 CFR §878-4810) Legally Marketed Predicate Devices: Cynosure, Inc.’s Revlite Q-Switched Nd:YAG Laser System (K133254) Laseroptek Co. Ltd.’s Helios II Q-Switched… | 2014 |
| * | K083203 | Helios II Q-Switched ND:Yag Laser SystemSummary page 4…System (K133254) Laseroptek Co. Ltd.’s Helios II Q-Switched Nd:YAG Laser System (K083203) Page | 1… | 2009 |
What descends from it? (5)
2 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 21 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 270 ancestors have a recall of any class.
- Of its descendants, K212663 (Laseroptek Co., Ltd., 2022) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K133254.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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
(1064 nm)
Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm)
Tattoo Removal: Dark ink (blue and black) (1064 nm)
Tattoo Removal: light ink (red, sky blue, green) (532 nm)
port wine birthmarks (532 nm)
telangiectasias (532 nm)
spider angioma (532 nm)
cherry angioma (532 nm)
spider nevi (532 nm)
cafe-au-lait birthmarks (532 nm)
solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 nm)
nevus of ota (1064 nm)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152856: Helios III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152856
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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