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510(k) Data Aggregation
K Number
K240474Device Name
Multi-function Platform Systems (BL-M10)
Manufacturer
Shanghai Bele Medical Technology Co.,Ltd
Date Cleared
2024-05-20
(90 days)
Product Code
GEX, ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Bele Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
(1) IPL: The Therapy IPL is intended for medical use in the following dermatologic conditions: Permanent hair reduction- long-terms table reduction in number of hairs re-growing after a treatment - 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 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 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: Y AG Laser: The Picosecond Nd: Y AG Laser is intended for use in surgical and aestheir 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 532mm wavelength of the Picosecond Nd: Y AG 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). - 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.
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 isolative 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.
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K Number
K240386Device Name
Picosecond Nd:YAG Laser Systems (BL-C10)
Manufacturer
Shanghai Bele Medical Technology Co.,Ltd
Date Cleared
2024-05-16
(98 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Bele Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Device Description
The BL-C10 Picosecond ND:YAG Laser Systems is designed with a mains electricity (AC-powered) light amplification by stimulated emission of radiation (LASER) device assembly based on neodymium-doped yttrium-aluminium-garnet (Nd:YAG) and frequency-doubled Nd:YAG laser technology. The laser system generates ultra-short pulses in the picosecond range (1 picosecond = 10^-12 seconds). The pulses are then amplified within the Nd:YAG crystal. The system operates at two wavelengths: 1064nm and 532mm. These wavelengths are chosen to target different colors of pigments in tattoos and pigmented lesions.
- 1064nm Wavelength: Used for treating tattoos with colors like black, brown, green, blue, and purple, as well as for treating benign pigmented lesions.
- 532nm Wavelength: Used for removing tattoos with colors such as red, yellow, and for treating benign pigmented lesions. The ultra-short pulses have very high peak power, allowing them to interact with target (tattoos or pigmented lesions) in a precise and controlled manner. The short duration of the pulses helps minimize heat buildup in surrounding tissues.
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K Number
K231131Device Name
Diode Laser Body Sculpture Systems
Manufacturer
Shanghai Bele Medical Technology Co.,Ltd
Date Cleared
2023-06-22
(62 days)
Product Code
PKT
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Bele Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
Device Description
The BL-A10 is a 1060nm Diode Hyperthermic Laser Lipolysis system and is the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce fat in areas such as flank and abdomen. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. It is designed to meet international safety and performance standards.
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