WaveLight FS200 Patient Interface
FDA 510(k) K190392 · Alcon Laboratories, Inc.
510(k) numberK190392
Submission
- Device name
- WaveLight FS200 Patient Interface
- Applicant
- Alcon Laboratories, Inc.
Lake Forest, CA, US - Received
- February 19, 2019
- Decision date
- March 26, 2019
- 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 WaveLight FS200 Patient Interface cleared by the FDA?
WaveLight FS200 Patient Interface (K190392) received a 510(k) decision of Substantially Equivalent on March 26, 2019, 35 days after the submission was received.
What is the product code of K190392?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.