Greenlight Moxy Fiber Optic
FDA 510(k) K120870 · American Medical Systems
510(k) numberK120870
Submission
- Device name
- Greenlight Moxy Fiber Optic
- Applicant
- American Medical Systems
San Jose, CA, US - Received
- March 22, 2012
- Decision date
- June 15, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Greenlight Moxy Fiber Optic cleared by the FDA?
Greenlight Moxy Fiber Optic (K120870) received a 510(k) decision of Substantially Equivalent on June 15, 2012, 85 days after the submission was received.
What is the product code of K120870?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.