Laser Indirect Ophthalmoscope 500(LIO-500)
FDA 510(k) K113390 · Meridian AG
510(k) numberK113390
Submission
- Device name
- Laser Indirect Ophthalmoscope 500(LIO-500)
- Applicant
- Meridian AG
Greenwood Village, CO, US - Received
- November 16, 2011
- Decision date
- February 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- 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. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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Questions and answers
When was Laser Indirect Ophthalmoscope 500(LIO-500) cleared by the FDA?
Laser Indirect Ophthalmoscope 500(LIO-500) (K113390) received a 510(k) decision of Substantially Equivalent on February 14, 2012, 90 days after the submission was received.
What is the product code of K113390?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.