Lasertx - Diode Laser & Delivery System
FDA 510(k) K060326 · Prosurg, Inc.
510(k) numberK060326
Submission
- Device name
- Lasertx - Diode Laser & Delivery System
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- February 9, 2006
- Decision date
- April 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Lasertx - Diode Laser & Delivery System cleared by the FDA?
Lasertx - Diode Laser & Delivery System (K060326) received a 510(k) decision of Substantially Equivalent on April 5, 2006, 55 days after the submission was received.
What is the product code of K060326?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.