Endoscopic Laser Delivery System-Lasertx
FDA 510(k) K023257 · Prosurg, Inc.
510(k) numberK023257
Submission
- Device name
- Endoscopic Laser Delivery System-Lasertx
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- September 30, 2002
- Decision date
- March 28, 2003
- 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 Endoscopic Laser Delivery System-Lasertx cleared by the FDA?
Endoscopic Laser Delivery System-Lasertx (K023257) received a 510(k) decision of Substantially Equivalent on March 28, 2003, 179 days after the submission was received.
What is the product code of K023257?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.