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510(k) Data Aggregation
K Number
K222265Device Name
Diosculpt
Manufacturer
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.
Date Cleared
2022-09-23
(57 days)
Product Code
PKT
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DioSculpt laser system 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.
Device Description
The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.
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K Number
K161356Device Name
Matrix LS-40 CO2 Laser System
Manufacturer
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD.
Date Cleared
2016-09-09
(116 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- Laser skin resurfacing.
- Treatment of furrows and wrinkles.
- Removal of skin taqs, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- Blepharoplasty.
- Site preparation for hair transplants.
- The fractional scanner is for skin resurfacing.
Device Description
The MATRIX LS-40 CO2 Surgical laser System incorporating a permanently articulated arm that delivers CO2 laser power in a wavelength of 10,600nm in its normal operations. The device is activated by means of a footswitch.
The Laser System is designed for use in an office or a clinic, which shall be a clean, dry and well-ventilated room with a door.
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