510(k) · Cleared
ClearedIPL Treatment Device (MDSQMC-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medusa (Guangxi)Medical Devices Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Jul 3, 2025 as substantially equivalent to K230816 (Shangdong Huamei Technology Co., Ltd., 2023) and 2 other predicates after a 276-day review. Its family tree reaches back 21 generations to 1992.
- Decided
- Jul 3, 2025
- Review
- 276 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K910422 (1992). 332 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 17 generations between
- 3 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 2 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 1 generation backK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- This deviceK243123 IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd. · 2025
Show all 21 generations
- Root · 21 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 20 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 19 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 18 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 17 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 16 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 15 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 14 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 13 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 12 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 11 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 10 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 9 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 8 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 7 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 6 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 5 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 4 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 3 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 2 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 1 generation backK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- This deviceK243123 IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −20 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −19 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −18 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −17 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −16 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −15 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −14 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −13 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −12 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −11 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −10 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −9 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −8 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −7 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −6 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −5 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −4 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −3 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| −2 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| −1 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
| 0 (this device) | K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 24 | 0 |
| 1998 | 19 | 0 |
| 1999 | 13 | 0 |
| 2000 | 26 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 30 | 0 |
| 2004 | 17 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K230816 | Intense Pulsed Light Treatment SystemSummary page 6…10(k) Number Approval Date The Intense Pulsed Light Shangdong Huamei Treatment System, (Model: K230816 April 21, 2023 Technology Co., Ltd. HM-IPL-B8) Reference device: Manuf… | 2023 |
| * | K192519 | Multi-modality workstationSummary page 6…al Date Beijing Superlaser IPL Treatment Device, November 6, K192519 Technology Co., Ltd. (Model: AAD Dual Light) 2019 Stellar… | 2019 |
| * | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemSummary page 6…se Pulsed Light (IPL) and Laser January 16, Lumenis Ltd. K193500 system 2020 IV. Device Description The IPL T… | 2020 |
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 33 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 332 ancestors have a recall of any class.
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. 2025, 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 Device (Model: MDSQMC-01) is intended for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Mild to moderate inflammatory Acne (Acne vulgaris)
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 regimen.
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/K243123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243123: IPL Treatment Device (MDSQMC-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243123
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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