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510(k) Data Aggregation
K Number
K042439Device Name
AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
Manufacturer
Date Cleared
2004-10-07
(28 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DIAMOND AGE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.
Device Description
The, Azuryt Model CTL 1401 CO₂ Surgical Laser System is a CO₂ laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcomputer and control panel.
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