Monteris Medical NeuroBlate System
FDA 510(k) K171255 · Monteris Medical, Inc.
510(k) numberK171255
Submission
- Device name
- Monteris Medical NeuroBlate System
- Applicant
- Monteris Medical, Inc.
Plymouth, MN, US - Received
- April 28, 2017
- Decision date
- July 25, 2017
- 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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| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
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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 |
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More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262315 | NeuroBlate SystemONO · Traditional | 09/03/2026SE |
| K260976 | NeuroBlate SystemONO · Special | 04/23/2026SE |
| K240877 | Monteris Medical NeuroBlate SystemONO · Traditional | 06/04/2024SE |
| K231061 | NeuroBlate SystemGEX · Traditional | 12/08/2023SE |
| K222983 | NeuroBlate Fusion-S Software V3.17GEX · Traditional | 03/15/2023SE |
| K201056 | NeuroBlate SystemGEX · Traditional | 08/21/2020SE |
| K193375 | NeuroBlate SystemGEX · Special | 01/03/2020SE |
| K182036 | NeuroBlate SystemGEX · Traditional | 10/15/2018SE |
| K173305 | NeuroBlate SystemGEX · Special | 11/17/2017SE |
| K172881 | NeuroBlate SystemGEX · Special | 10/20/2017SE |
Questions and answers
When was Monteris Medical NeuroBlate System cleared by the FDA?
Monteris Medical NeuroBlate System (K171255) received a 510(k) decision of Substantially Equivalent on July 25, 2017, 88 days after the submission was received.
What is the product code of K171255?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.