# K240474: Multi-function Platform Systems   (BL-M10)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Bele Medical Technology Co.,Ltd
- Decided: May 20, 2024 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K943450 (1995). 637 ancestors in all.
No later device cites it as a predicate yet.
0 of 638 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200746: IPL Treatment Systems, Shanghai Apolo Medical Technology Co., Ltd. (2020) Summary page 6.
- K200118: Diode Laser Therapy Device, Shanghai Apolo Medical Technology Co., Ltd. (2020) Summary page 6.
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules, Alma Lasers, Inc. (2018) Summary page 7.
- K233018: PICOSECOND Nd:YAG Laser System, Ids, Ltd. (2023) Summary page 7.
- K203395: Platform treatment system, Shanghai Apolo Medical Technology Co., Ltd. (2022) Summary page 7.
- K192856: MT One, M&T S.R.L. (2020) Summary page 7.

## Indications for use
(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.

Source page: https://510kreport.com/device/K240474
Methodology: https://510kreport.com/methodology