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510(k) Data Aggregation
K Number
K013047Device Name
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
Manufacturer
Date Cleared
2001-12-06
(87 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MOJCA VALIJAVEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:
- To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
- For removal of unwanted hair. ◆
- For coagulation and hemostasis of vascular lesions.
- For incision/excision of soft body tissue in dermatology .
- For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation
Device Description
The family of Fotona Dualis systems is based on the Nd: YAG laser technology. Within the systems, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming bearns are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
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