Indigo Laseroptic Treatment System
FDA 510(k) K003952 · Ethicon Endo-Surgery, Inc.
510(k) numberK003952
Submission
- Device name
- Indigo Laseroptic Treatment System
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- December 21, 2000
- Decision date
- March 16, 2001
- 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 Indigo Laseroptic Treatment System cleared by the FDA?
Indigo Laseroptic Treatment System (K003952) received a 510(k) decision of Substantially Equivalent on March 16, 2001, 85 days after the submission was received.
What is the product code of K003952?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.