Resurfx 1565NM Laser Module
FDA 510(k) K130028 · Lumenis, Ltd.
Submission
- Device name
- Resurfx 1565NM Laser Module
- Applicant
- Lumenis, Ltd.
Binyamina, IL - Received
- January 3, 2013
- Decision date
- September 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for…
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Questions and answers
When was Resurfx 1565NM Laser Module cleared by the FDA?
Resurfx 1565NM Laser Module (K130028) received a 510(k) decision of Substantially Equivalent on September 3, 2013, 243 days after the submission was received.
What is the product code of K130028?
The FDA product code is ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output, a Class II (moderate risk) device regulated under 21 CFR 878.4810.