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510(k) Data Aggregation
K Number
K140249Device Name
LONG PULSE ND: YAG LASER SYSTEM
Manufacturer
ADVANCED TECHNOLOGY LASER CO., LTD.
Date Cleared
2014-10-08
(250 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED TECHNOLOGY LASER CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Long pulse Nd:YAG Laser System is intended for use for :
• Benign pigmented lesions such as but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, sebortheic karatoses, nevi, chloasma, verucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.
• Pigmented lesions to reduce lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Device Description
The Long Pulse Nd:YAG Laser System is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser system. Pulsed laser energy at a nominal wavelength of 10641m. This wavelength causes maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
Deeper penetration and a more moderate hemoglobin absorption makes 1064 nm wavelength more useful for the deeper hair follicles and vessels. Further, with the right combination of parameters, the 1064 nm wavelength is also suitable for more superficial hair, telangiectasia and spider veins.
Base on this, Long Pulse Nd: Y AG Laser System is intended for 1) Benign pigmented lesions such as ,but not limited to , lemtigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss (significant reduction in the intensity of black and/or blue black tattoos) and plaques. 2) Pigmented lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. 3) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Nd: Y AG Laser System consists of control system, user interface, power source , laser emission and delivery system, cooling system and safety features
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K Number
K101555Device Name
CO2 LASER SYSTEM
Manufacturer
ADVANCED TECHNOLOGY LASER CO., LTD.
Date Cleared
2010-09-17
(105 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED TECHNOLOGY LASER CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eBeam CO2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to:
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty
Site preparation for hair transplants
Dental procedure including but not limited to -
Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision);
Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis
Podiatry procedures including but not limited to -
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.
This device is for prescription use only.
The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.
Device Description
eBeam CO2 Laser System is an intelligent sealed-off CO2 laser. eBeam CO2 Laser System delivers laser energy to the treatment site via a 7-joint spring-balanced articulated arm in which mirrors reflect the laser beam along the axis of arms to enter the output device- the specially designed handpiece.
eBeam CO2 Laser System can produce a laser beam with a wavelength of 10.6 m which is effective on all soft tissues, thus it can be used in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.
eBeam CO2 Laser System consists of control system, user interface, power supply, laser emission and delivery system, cooling system, safety features and handpieces (including scanning handpiece and normal handpiece).
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K Number
K102050Device Name
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
Manufacturer
ADVANCED TECHNOLOGY LASER CO., LTD.
Date Cleared
2010-07-29
(8 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED TECHNOLOGY LASER CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf6-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles
Device Description
The Q-Switched Nd: YAG Laser System is a new device for 510(k) submission and shares the same indications for use and safety compliance, similar design features and functional features with the predicate device.
The Q-Switched Nd:YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.
The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
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K Number
K083918Device Name
ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250
Manufacturer
ADVANCED TECHNOLOGY LASER CO., LTD.
Date Cleared
2009-02-02
(34 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED TECHNOLOGY LASER CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -
- A Treatment of furrows and wrinkles
- A Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation,
- A Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- A Blepharoplasty
- V Site preparation for hair transplants
Dental procedure including but not limited to
- ア Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivonlasty (incision and excision)
- > Oral Surgery procedures such as - aphous ulcer excision, frenectorny, benignimalignant lesion ablation, operculectomy and homeostasis
Podiatry procedures including but not limited to -
- > Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
- ア Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, LAUP and papillomatosis polyps.
Gynecology
- V Treatment of condyloma acuminata, cervical intracpithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasja.
Device Description
The ATL Family of CO2 Medical Laser Systems is a microprocessor-controlled CO2 laser system using a sealed laser tube providing either 15 watts maximum power (ATL-150) or 25 watts maximum power (ATL-250).
The ATL Family of CO2 Medical Laser Systems is intended to be used to deliver 10.6um CO2 light energy in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties.
The ATL Farnily of CO2 Medical Laser Systems covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
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K Number
K083915Device Name
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
Manufacturer
ADVANCED TECHNOLOGY LASER CO., LTD.
Date Cleared
2009-01-29
(30 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED TECHNOLOGY LASER CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow:
1. Intense Pulse Light Energy Wavelengths from 400 950 nm are indicated for the treatment of inflammatory acne.
2. Intense Pulse Light Energy Wavelengths from 560 1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions includes port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melagenna, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
3. Intense Pulse Light Energy Wavelengths from 700 1200 nm are indicated for the treatment of unwanted hair (i.e., hair removal).
Device Description
Angelite Family of Intense Pulsed Light Systems
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