510(k) · Cleared
ClearedMultifunctional Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Honkon Technologies Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Oct 18, 2013 as substantially equivalent to K122995 (Beijing Kes Biology Technology Co., Ltd., 2013) and 1 other predicate after a 116-day review. Its family tree reaches back 12 generations to 1992. 3 later devices descend from it.
- Decided
- Oct 18, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K910422 (1992). 91 ancestors in all, the oldest K885026 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- 2 generations backK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
- 1 generation backK122995 Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013
- This deviceK131859 Multifunctional SeriesBeijing Honkon Technologies Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK140668 Platinumgmt Ipl System CloudGlobal Medical Technology S.L. · 2014
- Descendant · 2 generations on · 1 of its ownK153717 Venus Versa SystemVenus Concept, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK232192 Venus Versa PRO SystemVenus Concept, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 7 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 6 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 5 generations backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 4 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 3 generations backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- 2 generations backK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
- 1 generation backK122995 Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013
- This deviceK131859 Multifunctional SeriesBeijing Honkon Technologies Co., Ltd. · 2013
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 |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −7 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −6 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −5 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| −4 | K053324 | Chromolite System | Chromogenex Plc | 2006 | — |
| −3 | K082484 | Accelawave System | Genesis Biosystems, Inc. | 2008 | — |
| −2 | K093627 | Ipulselight Ipl System, Models HS 300C and HS 650 | Shanghai Apolo Medical Technologies Co., Ltd. | 2011 | — |
| −1 | K122995 | Intense Pulsed Light (Ipl) Systems | Beijing Kes Biology Technology Co., Ltd. | 2013 | — |
| 0 (this device) | K131859 | Multifunctional Series | Beijing Honkon Technologies Co., Ltd. | 2013 | — |
| +1 | K140668 | Platinumgmt Ipl System Cloud | Global Medical Technology S.L. | 2014 | — |
| +2 | K153717 | Venus Versa System | Venus Concept, Ltd. | 2016 | — |
| +3 | K232192 | Venus Versa PRO System | Venus Concept, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 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 |
|---|---|---|---|
| * | K122995 | Intense Pulsed Light (Ipl) SystemsSummary page 2…585-1200 585-1200 585-1200 585-1200 585-1200 Les ions 5. Predicate Device Identification 510(k) Number: K 122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology'Technology Co.. Ltd.… | 2013 |
| * | K093627 | Ipulselight Ipl System, Models HS 300C and HS 650Summary page 2…umber: K 122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology'Technology Co.. Ltd. 510(k) Number: K093627 Predicate Device Name: IPULSELIGI-T IPL, SYSTEM Manufacturer: Shanghai APOLO Medical T'echnology Co., Ltd 6.… | 2011 |
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 |
|---|---|---|---|
| K140668 | Platinumgmt Ipl System Cloud | 2014 | 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 21 years and passes through 11 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 91 ancestors have a recall of any class.
- Of its descendants, K140668 (Global Medical Technology S.L., 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K122995.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in hair removal, moderate inflammatory acne, and benign cutaneous vascular lesions.
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/K131859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131859: Multifunctional Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131859
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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