Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family
FDA 510(k)Class II (US FDA 510(k))
by Fotona D.D.
Identifiers
- 510(k) Number
- K070355 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family is a laser system designed for medical applications. It utilizes Er:YAG and Nd:YAG laser technology to perform clinical procedures.
This device is authorized via FDA 510k clearance under K070355. It is manufactured by Fotona D.D. and is categorized under product code GEX.
Frequently asked questions
What technology does the Fotona Fidelis III system use?
The system utilizes both Er:YAG and Nd:YAG laser technologies. This combination allows the device to perform a variety of clinical procedures as designed for medical applications.
What is the regulatory status of the Fotona Fidelis III?
The Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family has received FDA 510k clearance under K number K070355. This indicates that the device was found to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of this laser system?
The device is manufactured by Fotona D.D., which is located in Ljubljana, Slovenia. The company is the applicant of record for the FDA 510k clearance associated with this system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070355 | Class II | Active |
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Manufacturer
- Manufacturer
- Fotona D.D.
Sources (1)
- FDA 510(k) K070355 24 fields · synced Oct 6, 2026