Excel Duopaulse Model 2000
FDA 510(k) K915679 · Excel Tech. , Ltd.
510(k) numberK915679
Submission
- Device name
- Excel Duopaulse Model 2000
- Applicant
- Excel Tech. , Ltd.
Holbrook, NY, US - Received
- December 19, 1991
- Decision date
- June 24, 1992
- 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 Excel Duopaulse Model 2000 cleared by the FDA?
Excel Duopaulse Model 2000 (K915679) received a 510(k) decision of Substantially Equivalent on June 24, 1992, 188 days after the submission was received.
What is the product code of K915679?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.