510(k) · Cleared
ClearedIPL Treatment Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Apolo Medical Technology Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on May 15, 2020 as substantially equivalent to K093627 (Shanghai Apolo Medical Technologies Co., Ltd., 2011) after a 53-day review. Its family tree reaches back 11 generations to 1992. 5 later devices descend from it.
- Decided
- May 15, 2020
- Review
- 53 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). 5 later devices descend from it, 3 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 deviceK200746 IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK231394 Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK240482 Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK203395 Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK251545 Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240474 Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024
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 deviceK200746 IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd. · 2023 · cites it directly2descendants
- K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd. · 2024 · 2 generations on1descendant
- K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. · 2022 · cites it directly1descendant
- K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd. · 2025 · 3 generations on0descendants
- K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024 · cites it directly0descendants
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) | K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +1 | K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | 2023 | — |
| +2 | K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | 2024 | — |
| +1 | K203395 | Platform treatment system | Shanghai Apolo Medical Technology Co., Ltd. | 2022 | — |
| +3 | K251545 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025 | — |
| +1 | K240474 | Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd | 2024 | — |
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 |
|---|---|---|
| 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 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 4…atory Class: Class II Product code: ONF Review Panel General & Plastic Surgery III Predicate Devices 510(k) Number: K093627 Trade name: iPulseLight IPL System (HS 300C, HS 650) Common name: Laser surgical instrument for us… | 2011 |
What descends from it? (5)
3 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 28 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, K231394 (Smedtrum Medical Technology Co., Ltd., 2023) has gone furthest, with 2 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. 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 treatment system is intended for medical use in the treatment of the following dermatologic conditions:
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
- Moderate inflammatory acne vulgaris;
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- Cutaneous lesions including scars;
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200746: IPL Treatment Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200746
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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