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510(k) Data Aggregation
K Number
K052874Device Name
SOPRANO HAIR REMOVAL DIODE LASER
Manufacturer
MSQ (M2) LTD.
Date Cleared
2005-11-22
(41 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MSQ (M2) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOPRANO™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Device Description
The modified MSq SOPRANO™ Hair Removal Diode Laser System is comprised of the following components:
- Console Unit that includes the main CPU Board, Power Supply Units, . Control Panel, Service Panel, Cooling System, Keyswitch, Emergency Stop, and Isolating Transformer;
- Handpiece (with Connector) that includes Optical Head, Tissue Cooling . system (the cold plate) and Handpiece Trigger;
- Footswitch. .
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K Number
K042000Device Name
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
Manufacturer
MSQ (M2) LTD.
Date Cleared
2004-12-21
(148 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MSQ (M2) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are indicated for a variety of aesthetic and surgical applications in the medical specialties of general and plastic surgery and dermatology, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology.
The Lovely System models (Aria and Harmony) are intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Specific indications for different wavelengths and models are listed for Dermatology and Plastic Surgery, General Surgery, Genitourinary, Gynecology, Oral/Maxillofacial, Otorhinolaryngology/ Head and Neck (ENT), Ophthalmology, and Podiatry.
Device Description
The modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are comprised of the following main components:
- A system console that includes the control display, software and control electronics, keyswitch, emergency stop, cooling system, optics bench;
- Footswitch;
- Variety of handpieces and attachment accessories.
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K Number
K033946Device Name
LOVELY SYSTEM
Manufacturer
MSQ (M2) LTD.
Date Cleared
2004-04-05
(108 days)
Product Code
FTC, GEX
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
MSQ (M2) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lovely System models (Aria and Harmony) are intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of plastic surgery and dermatology as follows:
Lovely I (Aria) & Lovely II (Harmony) Models:
The Advanced Fluorescence Technology (AFT) with 420-950 nm wavelengths is indicated for:
- The treatment of moderate inflammatory acne vulgaris.
- The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles).
- . The treatment of cutaneous lesions including warts, scars and striae.
- The treatment of benign cutaneous vascular lesions including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, erytherna of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and voenous, malformations.
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction. ●
Lovely II (Harmony) Model:
The Nd: YAG lasers (1064nm) are indicated for:
- The removal of black, blue or green tattoos. .
- Coagulation and hemostasis of vascular lesions and soft tissue, including treatment and clearance of superficial and deep telangiectasias) and reticular veing (0.1-4.0 mm diameter) of the leg.
- The non-ablative treatment of facial wrinkles. .
Lovely II (Harmony) Model:
- The UVB Light source (300-380nm) is indicated for:
- The treatment of leukoderma, including vitiligo (acquired leukoderma). .
- The treatment of psoriasis, atopic dermatitis (eczema), and seborrheic dermatitis.
The Lovely System models are also indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Device Description
The Lovely is a platform for AFT, UVB and Nd:YAG Laser Technology for various Aesthetic and Cosmetic applications. The Lovely has an option to operate seven different handpieces that emits light at 300nm to 1064nm for the following applications:
- Hair removal 트
- Skin Rejuvenation 트
- I Vascular and Pigmented lesion
- 트 Moderate Acne
- 트 Deep leg veins
- . Tattoo removal
- 트 Psoriasis and vitiligo
The system includes:
- A light/laser system console (including software and control 트 electronics) that controls timing and dosing parameters. The console includes a water-cooling system used to remove heat from the power supply and the optical bench.
- A control and display panel including LCD and soft-keys. 트
- Seven optional handpiece(s) that includes the light source, 트 electronics and pipes of the water cooling system.
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K Number
K031819Device Name
DIO-DENT 10 DENTAL DIODE LASER
Manufacturer
MSQ (M2) LTD.
Date Cleared
2003-10-30
(140 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MSQ (M2) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include: Cosmetic Dentistry - Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth; Endodontology - Pulpotomy, Pulpotomy as an adjunct to root canal therapv; Periodontology - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket); Oral Soft Tissue Surgery - Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions. Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining
Device Description
The Dio-Dent 10 Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues. A fiber optic held by a handpiece delivers up to 10Watts laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.
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K Number
K030805Device Name
MYTHOS 500
Manufacturer
MSQ (M2) LTD.
Date Cleared
2003-05-21
(69 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MSQ (M2) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MYTHOS 500™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The MYTHOS 500™ System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Device Description
The MYTHOS 500™ system delivers pulsed infrared laser light with a 810nm±10% wavelength and a selectable fluence of 5-60J/cm2. The system enables two pulse modes: Long pulse and Pulse. The pulsed energy is delivered through a 10x12mm handpiece tip. The complete system consists of console and a handpiece connected to the system by an umbilical cord. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output the system requires simultaneous activation of the handpiece trigger and the footswitch. The handpiece tip is cooled to provide continuous skin cooling. Laser parameters and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.
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