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510(k) Data Aggregation
K Number
K172096Device Name
Fraxis
Manufacturer
Ilooda Co. LTD
Date Cleared
2017-08-09
(29 days)
Product Code
GEX, ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Ilooda Co. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery). otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
Device Description
The Ilooda Fraxis CO2 Laser is comprised of the following major components:
- The main console unit 1.
- 2. Delivery handpieces (2)
- 3. Footswitch.
- 4. Accessories
The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
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