510(k) · Cleared
ClearedMulti-function Platform Systems (BL-M10)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Bele Medical Technology Co.,Ltd · GEX Powered Laser Surgical Instrument
Cleared on May 20, 2024 as substantially equivalent to K200746 (Shanghai Apolo Medical Technology Co., Ltd., 2020) and 5 other predicates after a 90-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- May 20, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 25 generations to K943450 (1995). 637 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- 2 generations backK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- 1 generation backK200118 Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2020
- This deviceK240474 Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 12 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 11 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 10 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 8 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 7 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 6 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 5 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 4 generations backK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- 3 generations backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- 2 generations backK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- 1 generation backK200118 Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2020
- This deviceK240474 Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −12 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −11 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −10 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −8 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −7 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −6 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −5 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −4 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| −3 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| −2 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| −1 | K200118 | Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 11 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 28 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 35 | 0 |
| 1999 | 31 | 0 |
| 2000 | 36 | 0 |
| 2001 | 36 | 0 |
| 2002 | 44 | 0 |
| 2003 | 49 | 0 |
| 2004 | 37 | 0 |
| 2005 | 35 | 0 |
| 2006 | 22 | 0 |
| 2007 | 21 | 0 |
| 2008 | 27 | 0 |
| 2009 | 14 | 0 |
| 2010 | 8 | 0 |
| 2011 | 11 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K200746 | IPL Treatment SystemsSummary page 6…surgery and in dermatology Classification: Class II, 21 CFR 878.4810. Product Code: ONF Premarket Notification: K200746 Company name: Shanghai Apolo Medical Technology Co., Ltd. Trade Name of Device: Diode Laser The… | 2020 |
| * | K200118 | Diode Laser Therapy DeviceSummary page 6…Powered Laser Surgical Instrument Classification: Class II, 21 CFR 878.4810 Product Code: GEX Premarket Notification: K200118 Company name: Shanghai Apolo Medical Technology Co., Ltd. Trade Name of Device: Modified Alma… | 2020 |
| * | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Summary page 7…cal Instruments (& Accessories) Classification: Class II, 21 CFR 878.4810. Product Code: GEX, ILY Premarket Notification: K172193 Company name: Alma Lasers Inc. Trade Name of Device: PICOSECOND Nd:YAG Laser System Common nam… | 2018 |
| * | K233018 | PICOSECOND Nd:YAG Laser SystemSummary page 7…Common name: / Classification: Class II, 21 CFR 878.4810. Product Code: GEX Premarket Notification: K233018 Company name: IDS, Ltd. Trade Name of Device: Platform treatment system Common name:… | 2023 |
| * | K203395 | Platform treatment systemSummary page 7…wered Laser Surgical Instrument Classification: Class II, 21 CFR 878.4810. Product Code: ONF, GEX Premarket Notification: K203395 Company name: Shanghai Apolo Medical Technology Co., Ltd. Trade Name of Device: MT ONE Common… | 2022 |
| * | K192856 | MT OneSummary page 7…IPL) and laser System Classification: Class II, 21 CFR 878.4810. Product Code: GEX, ONG, ONF, ONE Premarket Notification: K192856 Company name: M&TS.R.L. IV. Device description The BL-M10 is a new platform treatment system with 12.1" displ… | 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 29 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 34 of the 637 ancestors have a recall of any class.
- 2 other devices also cite its predicate K200746.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
(1) IPL: The Therapy IPL is intended for medical use in the treatment of the following dermatologic conditions: - Permanent hair reduction- long-terms table 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…
Read the full statement (444 words)
(1) IPL: The Therapy IPL is intended for medical use in the treatment of the following dermatologic conditions: - Permanent hair reduction- long-terms table 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.
(2) Diode laser: Diode laser treatment handpiece (808nm) handset is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
3) Triple Diode laser: The device is intended for use in dermatologic and general surgical procedures. The Triple diode laser Module is intended for use in dermatology procedures requiring coagulation. The Triple diode laser Module is indicated for: - Benign vascular and vascular dependent lesions removal.
(4) Picosecond Nd:YAG Laser: The Picosecond Nd:YAG Laser is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types 1-III.
(5) 1064nm Long pulse Nd:YAG: The 1064nm Long pulse Nd:YAG is indicated for - Benign vascular lesions. - Superficial and deep telangiectasias (venulectasias). - Benign cutaneous lesions. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles. - Laser skin resurfacing procedures. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. - Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation). - Treatment of pseudofolliculitis barbae (PFB).
(6) Q-switch Nd:YAG laser: The Q-switch Nd:YAG Laseris Module indicated for: - Benign vascular and pigmented lesions, age spots. - Nevus spilus. - Tattoo removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240474 · printed Nov 3, 2026
Cite this page
510(k) Report. “K240474: Multi-function Platform Systems (BL-M10).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K240474
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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