Fiber One
FDA 510(k) K100746 · American Medical Systems
510(k) numberK100746
Submission
- Device name
- Fiber One
- Applicant
- American Medical Systems
Sunnyvale, CA, US - Received
- March 16, 2010
- Decision date
- June 11, 2010
- 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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| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
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| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 07/21/2026SE |
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| K120870 | Greenlight Moxy Fiber OpticGEX · Special | 06/15/2012SE |
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| K111118 | Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System…OTP · Special | 07/01/2011SE |
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Questions and answers
When was Fiber One cleared by the FDA?
Fiber One (K100746) received a 510(k) decision of Substantially Equivalent on June 11, 2010, 87 days after the submission was received.
What is the product code of K100746?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.