510(k) · Cleared
ClearedHelios IV 785
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 9, 2022 as substantially equivalent to K152856 (Laseroptek Co., Ltd., 2016) and 1 other predicate after a 290-day review. Its family tree reaches back 25 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 9, 2022
- Review
- 290 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K943450 (1995). 288 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 2 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 1 generation backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- This deviceK212663 Helios IV 785Laseroptek Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK230373 HELIOS 785 PicoLaseroptek Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK243780 HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK240752 Deka ToroEl.En S.P.A. · 2024
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 12 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 11 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 10 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 9 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 8 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 7 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 6 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 5 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 4 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 3 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 2 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 1 generation backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- This deviceK212663 Helios IV 785Laseroptek Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −12 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −11 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −10 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −9 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −8 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −7 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −6 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −5 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| −4 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −3 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −2 | K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −1 | K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| 0 (this device) | K212663 | Helios IV 785 | Laseroptek Co., Ltd. | 2022 | — |
| +1 | K230373 | HELIOS 785 Pico | Laseroptek Co., Ltd. | 2023 | — |
| +2 | K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025 | — |
| +2 | 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 | 10 | 0 |
| 2000 | 24 | 0 |
| 2001 | 24 | 0 |
| 2002 | 33 | 0 |
| 2003 | 23 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K152856 | Helios IIISummary page 5…te device Applicant Device Name 510(k) Number Laseroptek Co., Ltd. Helios III Q-Switched Nd:YAG Laser K152856 System Syneron Candela PicoWay Laser System K170597 Corporation 4… | 2016 |
| * | K170597 | PicoWay Laser SystemSummary page 5…Ltd. Helios III Q-Switched Nd:YAG Laser K152856 System Syneron Candela PicoWay Laser System K170597 Corporation 4. Device Description HELIOS IV 785 consist of a set of Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP N… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230373 | HELIOS 785 Pico | 2023 | 2 |
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 27 years and passes through 11 companies; a new generation was cleared every 9 months on median.
- 11 of the 288 ancestors have a recall of any class.
- Of its descendants, K230373 (Laseroptek Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K152856.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
[Indication for use of Q-switched Nd:YAG Laser] - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) - Tattoo Removal (1064nm, 532nm) * dark ink : blue and black (1064nm) » light ink : red, sky blue, green (532nm) - Treatment of Vascular Lesions (532nm) * port wine birthmarks » telangiectaias * spider angioma * cherry angioma *…
Read the full statement (145 words)
[Indication for use of Q-switched Nd:YAG Laser]
- Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm)
- Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm)
- Tattoo Removal (1064nm, 532nm)
* dark ink : blue and black (1064nm)
» light ink : red, sky blue, green (532nm)
- Treatment of Vascular Lesions (532nm)
* port wine birthmarks
» telangiectaias
* spider angioma
* cherry angioma
* spider nevi
- Treatment of Pigmented Lesions (1064nm, 532nm)
» café-au-lait birthmarks (532nm)
* solar lentiginos (532nm)
» senile lentiginos (532nm)
* becker's nevi (532nm)
* freckles (532nm)
* nevus spilus (532nm)
* nevus of ota (1064nm)
[Indication for use of Ti:Sapphire Laser]
- Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously.*
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/K212663 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212663: Helios IV 785.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212663
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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