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510(k) Data Aggregation
K Number
K232885Device Name
Dawn Diode Laser System
Manufacturer
Shanghai Wonderful Opto-Electrics Tech Co., Ltd.
Date Cleared
2024-02-28
(163 days)
Product Code
NVK, EEG, GEX, ILY
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
450 nm, 635 nm and 980 nm Diode Laser:
· Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening:
• Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy:
· Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
· Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue
- · Gingival troughing for crown impression
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Fibroma removal
- · Frenectomy and frenotomy
- · Oral papillectomies
- · Soft tissue crown lengthening
- · Treatment of aphthous ulcers
- · Treatment of herpetic lesions
- · Periodontology;
- · Laser soft tissue curettage
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- · Cosmetic Dentistry;
- · Laser-assisted bleaching/whitening of the teeth
- · Light activation for bleaching materials for teeth whitening
- · Implant recovery
810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
1064 nm Diode Laser in dentistry:
- · Excisional and incisional biopsies;
- · Excision and vaporization of herpes simplex I and II;
- · Frenectomy and frenotomy;
- · Gingivectomy;
- · Gingivoplasty;
- · Gingival incision and excision;
- · Hemostasis;
- · Implant recovery;
- · Operculectomy;
- · Pulpotomy and pulpotomy as an adjunct to root canal therapy;
- · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
· Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility):
· Treatment of aphthous ulcers and herpetic lesions
Device Description
The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch.
This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system.
The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.
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