Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001
FDA 510(k) K003953 · Ethicon Endo-Surgery, Inc.
510(k) numberK003953
Submission
- Device name
- Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001
- 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 Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001 cleared by the FDA?
Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001 (K003953) 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 K003953?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.