ProFlex CO2 Laser Fiber
FDA 510(k) K203799 · Innovaquartz, LLC
510(k) numberK203799
Submission
- Device name
- ProFlex CO2 Laser Fiber
- Applicant
- Innovaquartz, LLC
Phoenix, AZ, US - Received
- December 28, 2020
- Decision date
- September 20, 2021
- 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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More from Rhein Laser Technologies Co., Ltd.
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|---|---|---|
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDDGEX · Traditional | 05/03/2024SE |
| 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 |
| K050108 | Sureflex and Accuflex Laser Lithotripsy FibersGEX · Traditional | 03/14/2005SE |
| K994010 | Innovaquartz General Shape Laser FiberGEX · Traditional | 12/17/1999SE |
Questions and answers
When was ProFlex CO2 Laser Fiber cleared by the FDA?
ProFlex CO2 Laser Fiber (K203799) received a 510(k) decision of Substantially Equivalent on September 20, 2021, 266 days after the submission was received.
What is the product code of K203799?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.