Spphine Plus STM 3W Diode Laser
FDA 510(k) K110079 · Den-Mat Holdings, LLC
510(k) numberK110079
Submission
- Device name
- Spphine Plus STM 3W Diode Laser
- Applicant
- Den-Mat Holdings, LLC
Santa Maria, CA, US - Received
- January 11, 2011
- Decision date
- February 10, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Spphine Plus STM 3W Diode Laser cleared by the FDA?
Spphine Plus STM 3W Diode Laser (K110079) received a 510(k) decision of Substantially Equivalent on February 10, 2011, 30 days after the submission was received.
What is the product code of K110079?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.