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510(k) Data Aggregation
K Number
K240543Device Name
Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
Manufacturer
Medency S.r.l.
Date Cleared
2024-10-24
(240 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Medency S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rapido Medical Laser is generally indicated for use in incision, vaporization, ablation, cutting and hemostasis, or coagulation of soft tissue in General surgery, Gynecology, Neurosurgery, Endovascular coagulation (EVLT/EVLA), Urology, Podiatry and Orthopedics, Dermatology, Plastic surgery and Aesthetics, Otolaryngology (ENT) and Oral surgery.
Device Description
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K Number
K232222Device Name
Primo Dental Laser
Manufacturer
Medency S.r.l.
Date Cleared
2023-11-27
(124 days)
Product Code
NVK
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Medency S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Dental Soft Tissue Indications
incision, excision, vaporization and coagulation of oral soft-tissues including marginal and interdental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy
- Frenotomv
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Implant recovery
- Incision and drainage of abscess
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulpotomy as an adjunction to root canal therapy
- Reduction of gingival hypertrophy
- Soft-tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- Tissue retraction for impression
- Reduction of bacterial level (decontamination) and inflammation
2. Laser Periodontal Procedures
- Laser soft-tissue curettage
- Laser removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility).
3. Whitening
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
4. Pain Therapy
- Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor 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.
Device Description
Primo Dental Laser is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It's a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Primo Dental Laser is a medical device used for a great variety of dental treatment including Surgery, Decontamination, Biostimulation and Therapy. All this due to the selection of protocols favourable through a wide spectrum of specialties.
Laser radiation is produced by a laser diode. This component, a semiconductor, is able to produce a laser radiation with a wavelength characteristic of the semiconductor itself.
Primo Dental Laser has the following characteristics: is transportable and equipped with an internal battery to be independent from the power supply. Laser emission occurs with a wireless pedal control, also powered by batteries.
The radiation emitted by the diode laser is delivered to the optical fiber or through the use of an accessory.
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