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510(k) Data Aggregation
K Number
K251031Device Name
Fiber Laser Treatment Systems (HS-232,HS-233)
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2025-07-02
(90 days)
Product Code
ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K232409Device Name
Electromagnetic Stimulation Systems
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2024-04-10
(244 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electromagnetic Stimulation System is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
Device Description
The HS-591 Electromagnetic Stimulation System is a non-invasive therapeutic device which comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue of adult patients. The device is equipped with a color touch-screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch-screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
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K Number
K221770Device Name
Fiber Laser Treatment System
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2022-10-13
(114 days)
Product Code
ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
Device Description
The Fiber laser Treatment system (HS-230) is the desktop type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system), fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is a Erbium fiber laser, producing a pulsed beam of near-infrared light (1550nm) upon activation by a footswitch. The beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
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K Number
K203395Device Name
Platform treatment system
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2022-01-28
(436 days)
Product Code
GEX, ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Platform Treatment System can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.
(1) IPL Handpiece
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
- 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) Q-switched Nd: Y AG laser Handpiece (1064nm wavelength):
- Benign vascular and pigmented lesions, age spots:
- Nevus spilus:
- Tattoo removal.
(3) Long pulsed Nd:YAG Handpiece:
- Benign vascular lesions
- Superficial and deep telangiectasias (venulectasias)
- 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)
Device Description
The proposed device, Platform Treatment System, HS-900K can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. These five handpieces are (1) Intense Pulsed Light (IPL) Handpiece, (2) Q-switched Nd:YAG laser Handpiece and (3) Long pulsed Nd:YAG Handpiece. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use.
The main unit consists of:
- (1) The Power supply module: Controls electrical supply to the entire system.
- (2) The Control module: Controls and coordinates the various components of the system for optimum performance. It also contains the following control features:
- a) Key switch: Used to turn on and off the power supply. (Clockwise to turn on and counter clockwise to turn off)
- b) Emerqency turn off switch: The red button found in the front panel of the machine is used to immediately shut off the machine's power supply in case of any emergency. Depressing this button will cut off the power supply to the whole system. Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply. When this button is engaged remember to turn the key switch to the off position afterwards.
- c) The touch Screen: True color TFT LCD (Liquid Crystal Display) shows the operational settings and adjustments as well as system status is displayed on the screen.
- (3) The display module: Displays various information of the system and accept users' instruction.
- (4) High current capacitors: Delivers adequate electrical energy to guarantee sufficient power during operation.
- (5) Cooling system: Maintains a stable thermal environment for optimum performance.
- (6) Laser generator: The unit uses 110V 50/60Hz single-phase power supply. Its capability should be less than 2900W. Use a 25A (110V 50/60Hz), single-phase three-wire outlet at an international level.
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K Number
K201731Device Name
Diode Laser Body Sculpture System
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2020-09-10
(78 days)
Product Code
PKT
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diode Laser Body Sculpture Systems 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 HS-851 Diode Laser Body Sculpture Systems is a 1060nm Diode Hyperthermic Laser Lipolysis system and utilizes the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce stubborn fat in areas such as flank, abdomen, back and thighs. 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. The proposed device consists of the main unit, control unit with dedicated software and user interface, and the treatment applicators.
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K Number
K201109Device Name
CO2 Laser Therapy System
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2020-07-15
(79 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Laser Therapy System is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
Device Description
The CO2 Laser Therapy Systems generate a 10,600nm wavelength, which is absorbed by water in the tissue. The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).
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K Number
K200116Device Name
PicoSecond Nd: YAG Laser System
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2020-05-28
(128 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo 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 PicoSecond Nd: YAG Laser System is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpence, laser power supply, cooling system, display and control system.
The PicoSecond Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.
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K Number
K200746Device Name
IPL Treatment Systems
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2020-05-15
(53 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IPL treatment system is intended for medical use in the treatment of the following dermatologic conditions:
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
- 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.
Device Description
The IPL Treatment Systems utilizes an intense, visible, broad-spectrum pulse of light that when used with interchangeable filters, allowing it to selectively heat the target for different indications. The optical component is intended to drive the IPL energy to concentrate where the optical energy has selectively heated the target.
The Intense pulsed light (IPL) is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. The light-based component delivers optical energy that is absorbed by specific chromophores in the skin, which is converted to heat, according to the principle of selective photothermolysis.
The proposed device consists of the main unit, control panel and the treatment handpiece(s).
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K Number
K200118Device Name
Diode Laser Therapy Device
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2020-04-17
(87 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diode Laser Therapy Device 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 types (Fitzpatrick skin type I-VI), including tanned skin.
Device Description
The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 810nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system, laser system. The 755nm, 810nm, 1064nm handpieces with different treatment size are available for different models.
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K Number
K191349Device Name
980nm Diode Laser Therapy Device
Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
Date Cleared
2019-08-16
(88 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Apolo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HS-890A 980mm Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization , incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as vascular lesions and dental procedure.
Device Description
The Diode Laser Therapy Device is a desktop device which utilizes a semiconductor diode with invisible infrared radiation as a laser source (980nm). The laser power is delivered to the treatment via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system and laser system.
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