Multi-function Platform Systems (BL-M10)

Shanghai Bele Medical Technology Co.,Ltd

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

6

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K240474
Device name
Multi-function Platform Systems (BL-M10)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-02-20
Decision date
2024-05-20
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Hair removalAcne treatmentPigment treatmentVascular treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Therapy IPL 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. The Diode laser treatment handpiece (808nm) 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. 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. 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. 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). The Q-switch Nd:YAG Laser Module is indicated for: - Benign vascular and pigmented lesions, age spots. - Nevus spilus. - Tattoo removal.

Intended 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 

Device Description

The BL-M10 is a new platform treatment system with 12.1" display screen which combines IPL/ Diode Laser/Triple Diode Laser/ Picosecond Nd:YAG Laser/ 1064nm Long pulse Nd:YAG laser and Q-switch Nd:YAG Laser functions. This is 6 in 1 platform machine, that provides different function with attaching different hand pieces. The system is designed with a mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities in combination or in isolation for ablative and non-ablative treatment of skin surface. The system includes various energy sources and dedicated hand-pieces intended to apply the different energies to the skin for respective indications for use.

Summary parsed at:2026-06-01 05:27:38 UTC

Predicate devices

6

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