510(k) · Cleared
ClearedIPL + Diode Laser Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Globalipl Development Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Mar 25, 2020 as substantially equivalent to K161286 (Beijing Adss Development Co., Ltd., 2016) and 1 other predicate after a 114-day review. Its family tree reaches back 16 generations to 1992.
- Decided
- Mar 25, 2020
- Review
- 114 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K910422 (1992). 150 ancestors in all, the oldest K871179 (1987). No later device cites it as a predicate yet.
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations between
- 3 generations backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- 2 generations backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- 1 generation backK192516 Diode Laser 808nmBeijing Superlaser Technology Co., Ltd. · 2019
- This deviceK193328 IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd. · 2020
Show all 16 generations
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 15 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 14 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 13 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 12 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 11 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 10 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 9 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 8 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 7 generations backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- 6 generations backK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- 5 generations backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- 4 generations backK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
- 3 generations backK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
- 2 generations backK180353 Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd. · 2018
- 1 generation backK192516 Diode Laser 808nmBeijing Superlaser Technology Co., Ltd. · 2019
- This deviceK193328 IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −15 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −13 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −12 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −11 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −10 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −9 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −8 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| −7 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| −6 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| −5 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
| −4 | K141973 | Diode Laser Hair Removal System | Beijing Anchorfree Technology Co., Ltd. | 2014 | — |
| −3 | K162659 | Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. | 2017 | — |
| −2 | K180353 | Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2018 | — |
| −1 | K192516 | Diode Laser 808nm | Beijing Superlaser Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K193328 | IPL + Diode Laser Machine | Beijing Globalipl Development Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 13 | 0 |
| 2003 | 13 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 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 18.2 · 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 |
|---|---|---|---|
| * | K161286 | IPL Therapy MachineSummary page 8…8-4 510(k) Summary 6. Identification of Predicate Device Predicate Device 1: 510(k) Number: K161286 Product Name: IPL Therapy Machine Manufacturer: BEIJING ADSS DEVELOPMENT CO., LTD. Predicate Device 2: 5… | 2016 |
| * | K192516 | Diode Laser 808nm Cleared while this submission was under review Summary page 8…510(k) Number: K161286 Product Name: IPL Therapy Machine Manufacturer: BEIJING ADSS DEVELOPMENT CO., LTD. Predicate Device 2: 510(k) Number: K192516 Product Name: Diode Laser 808nm Manufacturer: Beijing Superlaser Technology Co., Ltd. 7. Non-Clinical Test Conclu… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 14 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 150 ancestors have a recall of any class.
- 2 other devices also cite its predicate K161286.
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. 2020, 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 IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions，and (inclusive of the handpiece used to deliver diode laser energy) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193328: IPL + Diode Laser Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193328
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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