Wavelight FS200 Laser System Model: FS200
FDA 510(k) K101006 · Alcon Research, Ltd.
510(k) numberK101006
Submission
- Device name
- Wavelight FS200 Laser System Model: FS200
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- April 12, 2010
- Decision date
- October 21, 2010
- 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 Wavelight FS200 Laser System Model: FS200 cleared by the FDA?
Wavelight FS200 Laser System Model: FS200 (K101006) received a 510(k) decision of Substantially Equivalent on October 21, 2010, 192 days after the submission was received.
What is the product code of K101006?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.