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510(k) Data Aggregation
K Number
K200693Device Name
K2 MOBILE
Manufacturer
HULASER, Inc.
Date Cleared
2020-11-19
(248 days)
Product Code
GEX, DEV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
HULASER, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K2 mobile laser is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows:
Endodontic procedures: Pulpotomy, Root canal therapy
Periodontal procedures: Sulcular debridement
Implant procedures: Implant recovery
Surgery procedures:
Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty
Other procedures:
Gingival troughing, Hemostasis and coagulation, Leukoplakia,
Treatment of aphthous-ulcer canker sores and herpetic,
Laser Assisted whitening,
Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle
Device Description
The dental diode laser (Model: K2 MOBILE) is a surgical device designed for a wide variety of dental soft tissue procedures. Diode laser is used as a source of invisible infrared radiation for this device and delivered to the treatment area through optical fiber is incorporated into a tip. The dental diode laser (Model: K2 MOBILE) is handpiece type using an internal rechargeable battery. The rechargeable battery charger are provided.
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