Supra Scan Delivery System
FDA 510(k) K100678 · Quantel Medical
510(k) numberK100678
Submission
- Device name
- Supra Scan Delivery System
- Applicant
- Quantel Medical
Clermont Ferrand, FR - Received
- March 10, 2010
- Decision date
- July 21, 2010
- 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 Supra Scan Delivery System cleared by the FDA?
Supra Scan Delivery System (K100678) received a 510(k) decision of Substantially Equivalent on July 21, 2010, 133 days after the submission was received.
What is the product code of K100678?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.