510(k) · Cleared
ClearedIntense Pulsed Light (Ipl) Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Kes Biology Technology Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Jan 22, 2013 as substantially equivalent to K093627 (Shanghai Apolo Medical Technologies Co., Ltd., 2011) after a 118-day review. Its family tree reaches back 11 generations to 1992. 16 later devices descend from it.
- Decided
- Jan 22, 2013
- Review
- 118 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K910422 (1992). 90 ancestors in all, the oldest K885026 (1989). 16 later devices descend from it, 7 citing it directly.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 2 generations backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- 1 generation backK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
- This deviceK122995 Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK161286 IPL Therapy MachineBeijing Adss Development Co., Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK192521 Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK131859 Multifunctional SeriesBeijing Honkon Technologies Co., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK192519 Multi-modality workstationBeijing Superlaser Technology Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK140668 Platinumgmt Ipl System CloudGlobal Medical Technology S.L. · 2014
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 6 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 5 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 4 generations backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 3 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 2 generations backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- 1 generation backK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
- This deviceK122995 Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. · 2016 · cites it directly5descendants
- K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. · 2019 · cites it directly3descendants
- K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd. · 2013 · cites it directly3descendants
- K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd. · 2019 · 2 generations on2descendants
- K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L. · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −6 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −5 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −4 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| −3 | K053324 | Chromolite System | Chromogenex Plc | 2006 | — |
| −2 | K082484 | Accelawave System | Genesis Biosystems, Inc. | 2008 | — |
| −1 | K093627 | Ipulselight Ipl System, Models HS 300C and HS 650 | Shanghai Apolo Medical Technologies Co., Ltd. | 2011 | — |
| 0 (this device) | K122995 | Intense Pulsed Light (Ipl) Systems | Beijing Kes Biology Technology Co., Ltd. | 2013 | — |
| +1 | K161286 | IPL Therapy Machine | Beijing Adss Development Co., Ltd. | 2016 | — |
| +1 | K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2019 | — |
| +1 | K131859 | Multifunctional Series | Beijing Honkon Technologies Co., Ltd. | 2013 | — |
| +2 | K192519 | Multi-modality workstation | Beijing Superlaser Technology Co., Ltd. | 2019 | — |
| +1 | K140668 | Platinumgmt Ipl System Cloud | Global Medical Technology S.L. | 2014 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K093627 | Ipulselight Ipl System, Models HS 300C and HS 650Summary page 2…530-1200 530-1200 560-1200 560-1200 590-1200 lesions 5. Predicate Device Identification 510(k) Number: K093627 Product Name: IPULSELIGHT IPL SYSTEM Manufacturer: Shanghai APOLO Medical Technology Co., Ltd 6. Device Description… | 2011 |
What descends from it? (16)
See all 167 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 1.8 years on median.
- 2 of the 90 ancestors have a recall of any class.
- Of its descendants, K161286 (Beijing Adss Development Co., Ltd., 2016) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K093627.
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 Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, skin rejuvenation, reduction of pigmented lesions, acne therapy, freckle, vascular lesions and facial blemish removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122995: Intense Pulsed Light (Ipl) Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122995
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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