SabreLine and SabreGuard Laser Fibers
FDA 510(k) K182831 · Coloplast Corp.
510(k) numberK182831
Submission
- Device name
- SabreLine and SabreGuard Laser Fibers
- Applicant
- Coloplast Corp.
Plymouth, MN, US - Received
- October 9, 2018
- Decision date
- December 10, 2018
- 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 SabreLine and SabreGuard Laser Fibers cleared by the FDA?
SabreLine and SabreGuard Laser Fibers (K182831) received a 510(k) decision of Substantially Equivalent on December 10, 2018, 62 days after the submission was received.
What is the product code of K182831?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.