Sureflex and Accuflex Laser Lithotripsy Fibers
FDA 510(k) K050108 · Innovaquartz
510(k) numberK050108
Submission
- Device name
- Sureflex and Accuflex Laser Lithotripsy Fibers
- Applicant
- Innovaquartz
Phoenix, AZ, US - Received
- January 18, 2005
- Decision date
- March 14, 2005
- 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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| K180140 | ProFlex Laser FibersGEX · Traditional | 04/20/2018SE |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)GEX · Traditional | 12/19/2014SE |
| K994010 | Innovaquartz General Shape Laser FiberGEX · Traditional | 12/17/1999SE |
Questions and answers
When was Sureflex and Accuflex Laser Lithotripsy Fibers cleared by the FDA?
Sureflex and Accuflex Laser Lithotripsy Fibers (K050108) received a 510(k) decision of Substantially Equivalent on March 14, 2005, 55 days after the submission was received.
What is the product code of K050108?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.