NeuroBlate System
FDA 510(k) K201056 · Monteris Medical, Inc.
510(k) numberK201056
Submission
- Device name
- NeuroBlate System
- Applicant
- Monteris Medical, Inc.
Plymouth, MN, US - Received
- April 21, 2020
- Decision date
- August 21, 2020
- 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 |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| 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 |
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 |
| 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 |
| K171255 | Monteris Medical NeuroBlate SystemGEX · Traditional | 07/25/2017SE |
Questions and answers
When was NeuroBlate System cleared by the FDA?
NeuroBlate System (K201056) received a 510(k) decision of Substantially Equivalent on August 21, 2020, 122 days after the submission was received.
What is the product code of K201056?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.