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510(k) Data Aggregation
K Number
K113212Device Name
DENTAL LASER THERAPY SYSTEM
Manufacturer
Date Cleared
2011-11-16
(15 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CHINA DAHENG GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PenLase is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:
- Excision and Incision Biopsies
- Hemostatic assistance
- Treatment of Apthous Ulcers
- Frenectomy
- Frenotomy
- Gingival Incision and Excision
- Gingivectomy
- Gingivoplasty
- Incising and Draining of Abscesses
- Operculectomy
- Oral Papillectomy
- Removal of Fibromas
- Soft Tissue Crown Lengthening
- Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
- Tissue retraction for Impression
- Vestibuloplasty
Device Description
PenLase is a surgical equipment, simple tool, portable, and easy to use. It is a tool that can be used for the treatment of oral soft tissue surgery, plastic surgery.
The PenLase utilizes a semiconductor diode which consists of semiconductor "chips" made from Aluminum, Gallium and Arsenide, together commonly referred to as AlGaAs , with invisible infrared radiation as a laser source. The laser power is delivered to the treatment area via a fiber tip. The disposable fiber tips are bendable in a variety of angle for maximum access to all areas of the mouth.
PenLase delivers 0.7 Watts and 1.7 Watts with wavelength 810±10 nm of continue laser power without cords, outlets or foot switches, which makes its battery life last longer.
The PenLase charging station recharges up to two PenLase batteries simultaneously, a fully charged battery can last for several patients or procedures.
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K Number
K102669Device Name
DIODE LASER THERAPY SYSTEM
Manufacturer
Date Cleared
2010-11-17
(62 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CHINA DAHENG GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diode Laser Therapy System (DenLase-810/7 & DenLase-980/7) is indicated for intraoral use for the following soft tissue applications:
- Incision
- · Excision
- · Vaporization
- · Ablation
- · Coagulation.
Device Description
The DenLase is a surgical device designed with compactness, portability, reliability and user-friendliness. It provides the operator with a tool for surgical and cosmetic procedures on oral soft tissue. The Denlase utilizes a semiconductor diode with invisible infrared radiation as a laser source (810nm or 980nm). The laser power is delivered to the treatment area via a flexible fiber, which has a handpiece. The emission laser is activated by a footswitch. The Denlase adopts advanced semiconductor lasers (AIGAAs) and semiconductor refrigeration technology. By laser sent out by optical fiber, it can fast and accurately dispose tissue and lesion. The device includes three operation modes as continuous. single pulse and continuous pulse, and each operation mode is adjustable respectively by three parameter of emitting power, pulse width and pulse interval. The user can save total five groups of operation mode parameter combination under different mode.
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