510(k) · Cleared
ClearedIntense Pulsed Light Therapy Device (MMABM-1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micowey Medical Equipment (Guangxi) Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Sep 4, 2025 as substantially equivalent to K240482 (Smedtrum Medical Technology Co., Ltd., 2024) and 1 other predicate after a 107-day review. Its family tree reaches back 14 generations to 1992.
- Decided
- Sep 4, 2025
- Review
- 107 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K910422 (1992). 97 ancestors in all, the oldest K885026 (1989). No later device cites it as a predicate yet.
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations between
- 3 generations backK200746 IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020
- 2 generations backK231394 Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd. · 2023
- 1 generation backK240482 Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd. · 2024
- This deviceK251545 Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 12 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 11 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 10 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 9 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 8 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 7 generations backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 6 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 5 generations backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- 4 generations backK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
- 3 generations backK200746 IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020
- 2 generations backK231394 Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd. · 2023
- 1 generation backK240482 Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd. · 2024
- This deviceK251545 Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −13 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −11 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −10 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −9 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −8 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −7 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| −6 | K053324 | Chromolite System | Chromogenex Plc | 2006 | — |
| −5 | K082484 | Accelawave System | Genesis Biosystems, Inc. | 2008 | — |
| −4 | K093627 | Ipulselight Ipl System, Models HS 300C and HS 650 | Shanghai Apolo Medical Technologies Co., Ltd. | 2011 | — |
| −3 | K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| −2 | K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | 2023 | — |
| −1 | K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K251545 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025 | — |
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 | 8 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K240482 | Intense Pulsed Light System (ST-690)Summary page 5…(ST-690) Model ST-690 510(k) Number K240482 Product Code ONF Regulation Number… | 2024 |
| * | K041086 | Palomar Starlux Pulsed Light SystemSummary page 7…Predicate Device 2 510(k) Number K240482 K041086 INTENSE PULSED LIGHT THERAPY Device Name Intense Pulsed… | 2005 |
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 12 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 97 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 Intense Pulsed Light System is intended for medical use in the treatment of the following conditions, with treatment filters applied as indicated: 420-1200nm and 515-1200nm: Moderate inflammatory acne vulgaris. 515-1200nm and 560-1200nm: Benign pigmented epidermal lesions (including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)). 515-1200nm and 560-1200nm: Benign cutaneous vascular lesions (including port wine stains, hemangiomas…
Read the full statement (91 words)
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions, with treatment
filters applied as indicated:
420-1200nm and 515-1200nm: Moderate inflammatory acne vulgaris.
515-1200nm and 560-1200nm: Benign pigmented epidermal lesions (including dyschromia, hyperpigmentation, melasma,
and ephelides (freckles)).
515-1200nm and 560-1200nm: Benign cutaneous vascular lesions (including port wine stains, hemangiomas, facial,
truncal, and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas, and venous malformations).
590-1200nm, 640-1200nm and 695-1200nm: Permanent hair reduction (long-term stable reduction in the number of hairs
regrowing after a treatment regimen).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251545 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251545: Intense Pulsed Light Therapy Device (MMABM-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251545
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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