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510(k) Data Aggregation
K Number
K240482Device Name
Intense Pulsed Light System (ST-690)
Manufacturer
Smedtrum Medical Technology Co., Ltd.
Date Cleared
2024-05-17
(87 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Smedtrum Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions:
1. Moderate inflammatory acne vulgaris;
2. Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
3. Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
4. Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
Device Description
Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.
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K Number
K240118Device Name
Picosecond Nd:YAG Laser System
Manufacturer
Smedtrum Medical Technology Co., Ltd.
Date Cleared
2024-04-30
(105 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Smedtrum 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: such as tattoos removal and benign pigmented lesions.
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green 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
Picosecond Nd: YAG Laser Systems, pulse width: < 500ps; pulse energy up to 500mJ, instantaneous emission of laser energy efficient crushing lesions tissue chromophore, that is photon burst: laser accumulation energy is instantaneous emission. The instrument uses the laser-wave to break Chromatophore into pieces which can be naturally absorbed by the body. So that it achieves the purpose of de-freckling. The 1064 nm wavelength will shatter and removes the black, blue, purple and brown pigments while the 532 nm wavelength will shatter and removes red, pink, yellow and orange pigments of the tattoo or other pigmentations without damaging the normal tissue. Apply for tattoo and tattoo epidermal/ dermal lesion pigmented, lesions removal. Picosecond laser is being introduced as the first safe and effective aesthetic laser specifically designed to treat tattoos and pigmented lesions. This innovative laser delivers ultra short pulse bursts of energy to the skin in trillionths of a second. These pulses create a photomechanical effect, that target ink while avoiding unmarked tissue. The pulse shatters the ink into tiny, dust-like particles which are easily eliminated by the body.
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K Number
K231394Device Name
Intense Pulsed Light System
Manufacturer
Smedtrum Medical Technology Co., Ltd.
Date Cleared
2023-08-09
(86 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Smedtrum Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intense Pulsed Light System is intended for medical use in the following conditions:
1. Moderate inflammatory acne vulgaris;
2. Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
3. Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
4. Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
Device Description
Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.
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K Number
K230580Device Name
Diode Laser System
Manufacturer
Smedtrum Medical Technology Co., Ltd.
Date Cleared
2023-05-26
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Smedtrum Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size:
Single-Wavelength Handpiece
810nm wavelength
The 810nm wavelength handpiece is intended 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. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes)
Trio-Wavelength Handpiece
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 mm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).
Device Description
Diode Laser System is a photothermal effect surgical laser device intended for prescription use and is comprised mainly of three components: console, handpieces and water-loop cooling system. There is plenty of melanin in hair follicles and hair shafts. Melanin scatters among hair bulbs and shaft structures (like medullary substance, cortex, and cuticula pili). The laser wavelengths that ST-803 Diode Laser System uses can be well absorbed by melanin, which causes a rapid increase in temperature, destroying surrounding hair follicles, and finally removing hair. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The system can automatically identify different handpieces. The product includes 2 types of handpieces that are in the same spot size and 2 combinations of wavelengths.
The diode is exited to emit a high-power therapeutic laser beam intended to reduce unwanted body hair (e.g., armpit, leg, arm, back, chest and bikini line). It is intended to be used by a trained professional to emit a laser of wavelength around 810 nm or 755+810+1064 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat.
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K Number
K221597Device Name
CO2 Laser System
Manufacturer
Smedtrum Medical Technology Co., Ltd.
Date Cleared
2022-09-15
(105 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Smedtrum Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Laser System is used for body soft tissue ablation, vaporization and coagulation in dermatology, plastic surgery and general surgery.
Device Description
CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch. CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application.
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