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510(k) Data Aggregation
K Number
K242207Device Name
NOABLE LASER
Manufacturer
Date Cleared
2025-03-07
(221 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Daeju Meditech Engineering Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Device Description
NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode laser module. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue.
Based on state-of-the-art diode laser technology, the system offers many advantages, including the combination of the effective wavelengths, excellent pulse characteristics, and unique dynamic cooling device (DCD) and compact instrument. Laser is sent out through the diode laser module equipped inside the Main body to oscillate the laser and the user uses the touch LCD in the Main body and hand-piece to set the output parameters while controlling laser radiation through the foot switch and hand-piece switch. At this point, a coolant is sprayed from the end of the hand- piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.
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K Number
K242206Device Name
ACTIVO
Manufacturer
Date Cleared
2024-09-27
(60 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Daeju Meditech Engineering Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 mm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)
Device Description
The ACTIVO is based on the Nd:YAG(1064nm) and KTP Nd: YAG(532nm) laser technology. It is indicated for the incision, ablation, vaporization of soft tissues for general dermatology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy(1064nm). This converted light energy pumps the Nd: YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light(532nm). As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
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K Number
K211637Device Name
AROMA GRAND
Manufacturer
Date Cleared
2021-09-03
(99 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Daeju Meditech Engineering Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.
Permanent hair reduction is defined as the 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.
Device Description
The subject device. AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin tvpes (Fitzpatrick skin type I-VI).
It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece. The emission laser is activated by a footswitch.
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